Effect of orthodontic treatment on periodontal health of periodontally compromised patients:A randomized controlled clinical trial
To evaluate the effect of fixed orthodontic treatment on periodontal parameters in periodontally compromised adult orthodontic patients. This was a prospective, randomized, controlled clinical trial. Thirty-six periodontally compromised adult patients (mean age: 29.67 ± 4.8 years) were randomly allocated to either test (perio-ortho) or control group (perio). After periodontal stabilization in both groups, orthodontic treatment was started in the test group, whereas the control group remained on periodontal maintenance only. Evaluation and comparison of clinical parameters (plaque index [PI]; gingival index [GI]; bleeding on probing [BOP]; probing depth [PD]; clinical attachment level [CAL]) of both groups was assessed at three time intervals: T0 (base line), T1 (at start of orthodontic treatment), and T2 (1 year after start of orthodontic treatment). Radiological parameters (alveolar bone levels [ABL]) were recorded using CBCT at T1 and T2. Intragroup analysis showed statistically significant improvement in all clinical and radiological periodontal parameters in both groups (P ≤ .05). Intergroup comparison revealed improvement in the periodontal parameters was not statistically significant between the groups (P ≥ .05). Subgroup analysis showed reduction in the number of moderate and severe periodontitis sites in both groups with significant more gains in ABL in the test group compared to the control group. Orthodontic treatment after periodontal stabilization does not have any detrimental effect on periodontal health in adult periodontally compromised orthodontic patients and may add to the benefits achieved by periodontal treatment alone.ABSTRACT
Objectives
Materials and Methods
Results
Conclusions
INTRODUCTION
An increasing number of adult patients are now seeking orthodontic treatment due to an increased focus of society on esthetics and health consciousness. With the incidence of periodontal problems shown to increase with age, ortho-perio interactions play an important role in management of these patients.1 Orthodontic problems in the majority of these adult patients are a consequence of their underlying periodontal issues leading to reduced periodontal support and resulting in pathological migration, proclination of maxillary anterior teeth, interdental spacing, rotation and overeruption, resulting in compromised function and esthetics.2 Unfortunately there is no evidence-based solution to these problems and, with an increasing number of adults with malocclusion and compromised periodontium seeking orthodontic treatment, it is important to clarify the various issues involved in managing periodontally compromised dentitions. Orthodontic treatment in periodontally involved patients has been reported in a few clinical studies3,4 and case reports.5,6
A recent systematic review concluded that no evidence currently existed from controlled studies and randomized controlled clinical trials to show whether orthodontic treatment improves or aggravates the status of periodontally compromised dentitions.7 Hence, in the absence of conclusive evidence, orthodontists are unable to provide definitive answers to the queries of such patients. However, in many of these patients, reconstruction of occlusion and alignment of teeth with orthodontic treatment is necessary not only to prevent periodontal disease progression, but also to satisfy functional, esthetic, and communication demands. Therefore, it is important to understand the benefits and risks related to orthodontic treatment in periodontally compromised patients.
As orthodontic tooth movement is basically a bone remodeling phenomenon, the effect of orthodontic treatment on osseous topography in patients whose bone levels are already compromised is crucial.8 Therefore, in the present study, cone beam computed tomography (CBCT) was used to assess bony changes. The only CBCT study reporting the effects of orthodontic treatment on osseous parameters in periodontally compromised patients cited the lack of a control group as the limitation to making any solid conclusions.9
The present study was undertaken to study the effect of fixed orthodontic treatment on clinical and radiological periodontal parameters in periodontally compromised patients. This is the first randomized controlled study evaluating the effect of orthodontic treatment on periodontal health in periodontally compromised patients compared with a closely matched control group managed only by periodontal treatment.
MATERIALS AND METHODS
Trial Design, Registration
This was a prospective, randomized, controlled clinical study conducted in the Department of Orthodontics and Dentofacial Orthopedics in collaboration with the Department of Periodontology Post graduate institute of Dental Sciences (PGIDS), Rohtak, Haryana, India. The Consolidated Standards of Reporting Trials (CONSORT) guidelines were followed for the study (Figure 1). Ethical clearance from the Ethics Committee, Post Graduate Institute of Dental Sciences, Rohtak, Haryana, India, was obtained before starting the study (PGIDS/IEC/2018/12) and the trial was registered at clinicalTrials.gov. (NCT03914339).



Citation: The Angle Orthodontist 92, 3; 10.2319/022521-156.1
Subjects
The study sample was selected from patients reporting to the outpatient department (OPD) of Oral Diagnosis and Periodontology with the problem of moderate to severe plaque-induced periodontitis. Occlusion, function, and esthetics were evaluated in patients by investigators and Angle Class I non-extraction malocclusion patients who fulfilled the inclusion and exclusion criteria (Table 1) were selected for the study. Patients were given oral and written information about the study protocol and those who gave written consent were included in the trial.

Sample Size Calculation
A clinical attachment level (CAL) difference of 1.0 mm was considered to be of clinical importance between the test and control groups.7 To detect a clinically meaningful difference in CAL of 1.0 mm, standard deviation (SD) of 1.0 mm, with a power of 80%, and an α-level error of 0.05, 16 patients were needed in each group. Accounting for a 10% dropout rate, 18 patients were enrolled in each group (total: 36 patients).
Randomization and Allocation Concealment
All 36 patients received a detailed periodontal evaluation and parameters were recorded at T0. After periodontal stabilization, block randomization was achieved by an investigator (DK) not involved in providing orthodontic or periodontal treatment or analyzing results. A block size of 6 was chosen and possible balanced combinations with three tests and three controls were generated by using random allocation software.10 Further random selection of blocks was done for assignment of all 36 participants. Clinicians and patients were not blinded due to the research design. However, the person analyzing the data was blinded, as all patients and their data were numbered consecutively.
Test Group (Ortho-Perio, n = 18)
Patients receiving orthodontic treatment after treatment of periodontitis.
Control Group (Perio Only, n = 18)
Patients managed by achieving and maintaining stable periodontal health for the study duration. These patients were given the option of starting orthodontic treatment after 1 year.
Intervention
All 36 study sample patients received a detailed periodontal evaluation and all periodontal parameters used in the study were recorded at baseline (T0) (Figure 2). After achieving stability of periodontal results, orthodontic treatment was started in the test group only, while the control group was kept on monthly recall for the first 3 months and then every 1 to 3 months as per their periodontal requirements.



Citation: The Angle Orthodontist 92, 3; 10.2319/022521-156.1
Periodontal Management
Professional periodontal treatment was provided to all patients in both groups as per their requirements, including professional oral hygiene (POH) and periodontal surgery in the form of open-flap debridement in sites showing probing depths (PD) ≥ 5 mm that bled on probing even after scaling and root planing at the 4 to 6 week follow-up visit. All patients were prescribed 0.12% chlorhexidine mouth rinse twice daily for 2 weeks after surgery.
Orthodontic Treatment
Orthodontic treatment was started in the test group using preadjusted edgewise 0.022-in. MBT brackets (Ortho Organizers, Carlsbad, CA, USA) bonded with Enlight Light Cure Adhesive (Ormco Corp, Glendora, CA, USA) using an LED curing light (Galaxy, Light Cure Unit Cordless, Ahmedabad, India). Special considerations concerning force systems, anchorage, and retention were applied during orthodontic treatment11 (Figure 3):
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Use of Copper NiTi wires (Ormco) during leveling and alignment.
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Use of steel ligatures (0.010) and bonded buccal tubes, with special care taken to remove excess composite.
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Space closure performed using low and constant force levels. Anchorage, where needed, was provided by using miniscrews (FavAnchor, Pune, India).
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Fixed lingual bonded retainers for maxillary and mandibular anterior teeth will be provided to all patients after completion of treatment (Multi-strand stainless steel wire 0.0215-in., G&H Orthodontics, Franklin, IN, USA).



Citation: The Angle Orthodontist 92, 3; 10.2319/022521-156.1
Data Collection
Clinical parameters.
Clinical parameters were recorded for each patient by same investigator at three timepoints: T0: Baseline examination (before any orthodontic and or periodontal treatment); T1: At start of orthodontic treatment; and T2: 1 year after start of orthodontic treatment. At T2, major tooth movements such as alignment and leveling, space closure, and retraction had been completed in all patients; all patients were in the finishing stage; and none had completed treatment.
All clinical parameters were measured in the upper and lower anterior teeth with a manual periodontal probe (PCP-UNC 15; Hu-Friedy, Chicago, IL, USA) and mean values were calculated.
Radiological parameters.
Alveolar bone levels (ABL) were measured from the cementoenamel junction (CEJ) to the bone crest on all four surfaces of the maxillary and mandibular anterior teeth at T1 and T2 for both groups using CBCT (CS 9300). Parameters used were: field of view (FOV) 10 × 10 cm, voxel size: 180 μm, voltage 90kV, 4 mA current, and exposure time: 8 seconds.
For standardization, axial navigated coronal and sagittal reformatted sections were created so the tooth was visible at the center of its long axis in the mesio-distal and bucco-lingual planes. This enabled the entire length of the tooth from the incisal edge to root apex to be completely visible. A reference line was then drawn joining the mesial and distal CEJ in the coronal plane and buccal and lingual extent of the CEJ in the sagittal plane. The perpendicular distance of the marginal bone from this reference line was considered as the level of corresponding alveolar bone.
Subgroup analysis.
Subgroup analysis for PD and CAL sites were analyzed.12 Change in the number of sites of PD and CAL of these categories at T0, T1, T2 were evaluated and compared between the two groups.
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Mild periodontitis: PD < 4 mm, CAL: 1-2 mm.
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Moderate periodontitis: PD: 4-5 mm, CAL: 3-4 mm.
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Severe periodontitis: PD ≥ 6 mm, CAL: ≥ 5 mm.
Subgrouping of ABL was also done and further analyzed for a detailed evaluation of bone changes during orthodontic treatment.13
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Mild periodontitis: radiographic bone loss < 15%.
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Moderate periodontitis: radiographic bone loss: 15% to 33%
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Severe periodontitis: radiographic bone loss: 33% to 66%
Intra-Examiner Reproducibility
To determine reproducibility of the method, one co-investigator (ST) recorded clinical periodontal measurements for PD and CAL on 10 patients on two separate occasions with a 48-hour interval. Similarly, ABL on CBCT of 10 randomly selected teeth were re-measured by another co-investigator (AG). Kappa values of 0.83 for PD, 0.81 for CAL, and 0.81 for ABL suggested strong intraexaminer reliability.
Statistical Analysis
Data obtained was compiled on an MS Office Excel Sheet and statistical data analysis was performed using SPSS v 21.0 (IBM, Armonk, NY, USA). Normality of numerical data checked using Shapiro-Wilk revealed that data followed a normal curve. Paired t-tests were done for intra group and unpaired t-tests for intergroup comparisons were used to evaluate changes in clinical and radiological parameters at different time points (T0, T1, and T2). CAL, PD, and ABL changes in patients were evaluated by taking mean ± SD and comparison of changes in the frequencies of the three subgroups at different time intervals were evaluated using chi square test. For all statistical tests, P < .05 was considered to be statistically significant, keeping α error at 5% and β error at 20%, thus giving 80% power to the study.
RESULTS
All 36 patients completed the trial, and healing was uneventful in all patients.
Table 2 shows that there were no statistically significant differences at baseline in demographic, clinical, or radiological parameters between the two groups.

Table 3 shows the mean values and change in various clinical periodontal parameters in the test and control groups before (T0) and after (T2) treatment. There was a statistically significant improvement (P > .05) in all clinical periodontal parameters in both the groups at all-time intervals with no significant differences between the groups.

Table 4 shows that the radiological periodontal parameters (ABL) underwent statistically significant improvement from T1 to T2 in both groups. The mean ABL for test patients at T1 was 3.42 mm ±1.01 mm and at T2 was 2.94 mm ± 1.0 mm. Mean ABL at T1 for the control group was 3.40 mm ± 1.0 mm and at T2 was 3.05 mm ± 1.03 mm, resulting in a bone gain of 0.48 ± 0.29 mm in the test group and 0.35 ± 0.32 mm in the control group.

Subgroup Analysis (Table 5)
The number of sites in the mild, moderate, and severe categories of CAL, PD, and ABL were evaluated and a change in the frequencies of the three subgroups in the test and control groups was seen. In subgroup analysis for PD, there was a reduction in 99% of severe and 66% of moderate periodontitis sites and an increase of 42% in mild sites in the test group. A reduction in 97% of severe and 62% of moderate sites with an increase of 38% in mild sites in the control group was found.

CAL subgroup analysis showed a reduction in 71% of severe and 53% of moderate CAL sites in the test group with an increase of 55% in mild sites in the test group, while the control group showed a reduction in 54% of severe and 51% of moderate sites with an increase of 38% in mild sites. Again, the difference in the reduction of PD and CAL sites was not statistically significant between the groups (P ≥ .05). Subgroup analysis of ABL sites showed a similar trend of reduction in the number of severe and moderate bone sites and an increase in the number of mild sites in both groups. However, the improvement in ABL periodontitis sites was significantly (P = .004) greater in the test group than the control group.
DISCUSSION
The fact that orthodontic treatment has been shown to have small detrimental effects on the periodontium even in periodontally healthy individuals is a cause of concern, especially in an already compromised dentition.14 Systematic reviews on this issue have repeatedly cited a lack of scientific evidence on the effect of orthodontic treatment on osseous and non-osseous periodontal parameters in periodontally compromised patients.1,15 This study attempted to address whether it is safe to subject periodontitis patients to orthodontic therapy.16
The present study was designed as a randomized controlled trial (RCT) and aimed to evaluate the effects of orthodontic treatment on periodontal tissues in periodontally compromised dentitions by evaluating periodontal parameters before, during, and after orthodontic treatment with a closely matched control sample to clarify various issues involved in managing periodontally compromised dentitions. Untreated controls in which orthodontic treatment was not done are important to account for naturally occurring periodontal changes and to determine the influence of confounding factors, thus overcoming a major limitation mentioned in all earlier studies on this subject.14 The main problem encountered in the project was to convince the patients to agree to orthodontic treatment, mainly due to their apprehension that their teeth would loosen further due to orthodontic treatment, again stressing the need for controlled scientific evidence on this subject.
The results of the study showed favorable results of a combined periodontic-orthodontic treatment in periodontally compromised patients. There was a statistically significant improvement in all the periodontal parameters in the control and test groups with a highly significant CAL gain of 0.74 mm (CI: 0.64-0.83) and 0.98 mm (CI: 0.94-1.01), respectively, from T0-T2. Use of CBCT enabled evaluation of ABL changes on all four surfaces of upper and lower anterior teeth and showed statistically significant improvement in ABL from T1 to T2 in both groups.
In the absence of RCTs on orthodontic management of periodontally compromised patients, it was not possible to compare the findings of the present trial with other studies. Orthodontic treatment in periodontally compromised dentitions was mainly reported previously in case reports, case series, and a few clinical controlled trials, and most reported findings similar to the current trial, namely improvement in periodontal health parameters.17,18
However, loss of CAL and ABL has also been reported.19,20 Thus, positive and negative results have been reported. Also, most studies4,18 with positive results focused on the effect of orthodontic treatment in management of infrabony defects, reporting periodontal parameters in relation to the tooth with such defects. Absence of randomization and lack of a control group were some of the other limitations of those studies, deterring a definite, conclusive result. This was the first RCT on this subject and, hence, the results have great clinical significance.
Results of this study were similar to a recent RCT by Zasciurinskiene et al., which also showed CAL gain and PD reduction.7 However the ABL gain in that study was very small and insignificant compared to the current study in which significant bone gain was found. The authors mentioned lack of control group as their major limitation, due to which they were not able to come to a solid conclusion.
An important finding in the current study was that there was no adverse effect of orthodontic treatment on either osseous or non-osseous periodontal parameters in the test group, as evidenced by the non-significant difference between the two groups, with the values being toward greater improvement in the test group (Tables 3 and 4). This was reported in a few other studies with various reasons hypothesized for this positive effect of orthodontic treatment.21,22
Vardimon et al. hypothesized that bone repair could be due to orthodontic treatment acting as a mechanical stimulus.21 Ogihara et al.22 reported that mechanical stresses exerted on the alveolar bone led to activation of angiogenic growth factors like vascular endothelial growth factor, by which angiogenesis led to osteogenesis during bone formation and remodeling. Due to the clinical nature of the present study, these biochemical and histological findings could not be confirmed, but these are important findings to be verified by experimental studies.
The present trial provided an evidence-based conclusive answer that orthodontic treatment had no detrimental effect on the periodontal health in periodontally compromised patients if proper periodontal health was maintained throughout orthodontic treatment. Further studies with larger power, greater sample sizes, long-term follow-up, and exploring other aspects involved in routine treatment of adult orthodontic patients, are recommended to verify these results. Hence, a long-term follow-up of the results is being continued for this study too.
CONCLUSIONS
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Within the limitations of the study, it can be concluded that orthodontic treatment does not have a deleterious effect on periodontal health after periodontal stabilization in periodontally compromised patients.

CONSORT flow chart for the study. CONSORT indicates Consolidated Standards of Reporting Trials.

Patient intraoral pretreatment photographs, panoramic and cone beam computed tomographic images at T1.

Patient intraoral photographs, panoramic and cone beam computed tomographic images at T2.
Contributor Notes