Effect of Orthodontic Treatment on the Stability of Pre-Orthodontic Recession Coverage
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      This study attempts to assess the effect of orthodontic treatment on the stability of
      pre-orthodontic recession coverage by connective tissue graft- a randomized controlled
      clinical trial and thus facilitate better evidence based treatment protocol.
    

Detailed description: 
      Gingival recession is the location of the gingival margin apical to the cemento-enamel
      junction. The consequences of gingival recession range from impairment of esthetics,
      development of dentin hypersensitivity, root caries and an especially high incidence of
      non-carious cervical lesions.

      The etiology of gingival recession is held to be multifactorial with various predisposing and
      precipitating factors recognized. The most commonly implicated risk factors include bone
      dehiscence/fenestration, tooth malposition (especially facially positioned teeth), thin
      gingival phenotype, the narrow width of keratinized gingiva, frenum pull, the presence of
      gingival inflammation, overzealous toothbrushing, and faulty dental restorations. Apart from
      these, certain types of orthodontic tooth movements are also assumed to precipitate gingival
      recession although conclusive evidence in support of this postulation is still needed and if
      indeed true, the precise underlying mechanism still unclear.

      Most of the studies have focused on the contribution of orthodontic treatment induced incisor
      proclination (outside the dentoalveolar envelope) as a causative factor for the development
      of gingival recession and the findings have been indecisive. While some studies support this
      premise, others have observed no such correlation. Correspondingly, the issue of periodontal
      intervention in order to prevent development and/or progression of gingival recession in
      patients scheduled for orthodontic treatment remains unclear. One approach supports
      performing gingival augmentation prior to initiation of orthodontic tooth movement. The basis
      for this approach rests in the concept of the importance of the minimum amount of attached
      gingiva needed for dissipating forces of muscle pull, unattached mucosa and masticatory
      stresses and facilitation of patient performed oral hygiene procedures. Esthetic improvement,
      management of dentinal hypersensitivity and prevention of root caries are other expected
      benefits specifically associated with performing root coverage surgery. Moreover, improvement
      of gingival tissue dimensions before orthodontic tooth movement is expected to prevent
      further deterioration of preexisting gingival recession and better withstand orthodontic
      forces. Therefore, this approach is typically a preventive one. However, supporters of the
      other perspective, i.e. waiting for gingival augmentation surgery until after orthodontic
      treatment is over believe that it is best to wait until the gingival recession develops into
      a pathological entity and becomes a real clinical problem warranting corrective treatment. In
      fact, they regard the aforementioned preventive approach as a sort of 'overtreatment' and
      therefore avoidable. There are also concerns expressed regarding the long-term stability of
      gingival marginal levels achieved with mucogingival surgery performed before orthodontic
      tooth movement. Based on the above discussion, it is apparent that there is wide subjectivity
      regarding clinical decision making in cases where orthodontic treatment is planned in
      patients displaying gingival recession. Currently, both the indications as well as the timing
      of carrying out root coverage procedures in patients scheduled for orthodontic treatment are
      not very well elaborated. A thorough search of the literature revealed a very modest level of
      evidence - one study with prospective and retrospective data collection and the other a
      retrospective study. In both the studies, gingival augmentation surgery was carried out
      before the orthodontic intervention. Therefore, a need is felt for conducting a well-designed
      research in order to dissipate the conflict of opinions existing over this vital clinical
      issue. The high prevalence of gingival recession among patients needing orthodontic treatment
      renders this question even more vital. The current study has thus been conceived and designed
      so as to help resolve this clinical decision making conundrum. In the proposed study, a
      comparative evaluation of clinical and radiographic parameters pre and post-orthodontic
      treatment in teeth with gingival recession between participants undergoing gingival recession
      coverage before the initiation of orthodontic tooth movement with participants not undergoing
      pre-orthodontic root coverage will be done. The root coverage procedure chosen is
      sub-epithelial connective tissue graft since it is recognized as the gold standard among all
      recession coverage surgical procedures.

      The present prospective, analytical, randomized controlled clinical trial will be conducted
      in the Department of Periodontics and Oral Implantology in collaboration with Department of
      Orthodontics, Post Graduate Institute of Dental Sciences, Rohtak.

      Systemically healthy individuals having slight crowding in the anterior region, with at least
      one tooth having a gingival recession in the same region.

      Participants will be enlisted from the regular outpatient department of the Department of
      Periodontics and Oral Implantology, Department of Orthodontics and Department of Oral
      Medicine Diagnosis and Radiology after screening on the basis of inclusion and exclusion
      criteria as detailed above. All participants will be given an outline of the study design and
      all patient-specific considerations and concerns will be properly addressed. All participants
      will be required to provide written informed consent.

      All patients enrolled in the study will be further randomly divided into the following two
      groups using computer-generated randomization table using block randomization of 4 and 6 by
      the random allocation software system.

        1. Connective Tissue Graft before Orthodontic treatment (Test Group) - Scaling and root
           planing will be performed and after resolution of periodontal inflammation, root
           coverage will be done using subepithelial connective tissue graft. Orthodontic treatment
           will be initiated 3 months following the grafting procedure.

        2. Orthodontic treatment only (Control Group) - Scaling and root planing will be performed
           and after resolution of periodontal inflammation, orthodontic treatment will be
           initiated.

      Participants of both the groups will be regularly motivated and expected to maintain
      meticulous plaque control throughout the course of orthodontic treatment.

      Full mouth scaling and root planning will be performed using ultrasonic instruments and hand
      instruments as needed. After administration of local anaesthesia, a partial-thickness flap
      will be reflected with a horizontal incision 2 mm away from the tip of the interdental
      papilla, and two vertical incisions will be made from the gingival margin of the line angles
      of adjoining teeth. These incisions would extend at least one tooth wider mesiodistally than
      the area of gingival recession. The incisions will be extended to the mucobuccal fold. A
      connective tissue graft will be obtained from the palate near the gingival margin of molars
      and premolars. The palatal wound will be sutured to obtain primary wound closure. The
      connective tissue graft will then be placed on the denuded root surface and sutured to the
      periosteum using resorbable sutures. The outer portion of the graft will be covered with the
      partial thickness flap, and sutures will be placed interdentally. This will be followed by
      placement of periodontal dressing. All the patients will be treated with the same fixed
      mechanotherapy. Oral hygiene motivation and maintenance will be done during the entire course
      of orthodontic treatment. Once the levelling and alignment (approximately 6-8 months) of
      teeth has been completed, parameters will be recorded for both test group and control group.

      PRIMARY OUTCOME MEASURES A) Clinical:-

        -  Keratinized tissue width (KTW)

        -  Clinical attachment level(CAL)

        -  Recession depth (REC)

        -  Recession width

        -  Gingival Index(GI)

        -  Bleeding on Probing(BOP)

      SECONDARY OUTCOME MEASURES A) Clinical:-

        -  Plaque Index

        -  Root Esthetic Score(RES)

        -  Probing pocket depth(PPD)

        -  Gingival Biotype/Phenotype

        -  Percentage of Root coverage

        -  Patient-based Evaluation of pain, hypersensitivity, and ease of oral hygiene maintenance
           by questionnaire and Visual Analogue scale for pain (VAS).

      B) Radiographic:- Radiographic Investigations will be made at the start and at the end of the
      treatment using Customized bite blocks and parallel angle technique will be used to obtain
      Intra Oral periapical radiographs and measurements were calculated by using Image - J
      software.

      DATA COLLECTION METHODS

      Clinical:

      Using University of North Carolina (UNC) 15 periodontal probe to measure PPD, CAL, BOP,
      gingival recession at 3 sites (mesiobuccal, distal buccal and midbuccal) per tooth and at 4
      sites per tooth to measure PI and GI. The cemento-enamel junction will be used as a fixed
      reference point.

      Radiographic:

      Customized bite blocks and parallel angle technique will be used to obtain Intra Oral
      periapical radiographs and measurements were calculated by using Image- J software.

      DATA MANAGEMENT AND STATISTICAL ANALYSIS Data recorded will be processed by standard
      statistical analysis. The normality of distribution of data will be examined by Shapiro Wilk
      test. Statistical analysis will be performed according to the distribution of data. If found
      to be normal in distribution, intragroup comparison will be done by repeated ANOVA between
      different time points followed by paired T-test between two-time points and inter group
      comparison will be done by using Independent T-test between two groups. If it is in
      non-normal distribution, intragroup comparison will be done by Wilcoxon signed rank test and
      intergroup comparison will be done by Mann-Whitney U test. The Chi-square test will be
      applied to analyze categoric data. Correlation and association between predictors and
      dependent variables will be analyzed by correlation analysis and regression analysis.
    

Intervention name(s): Connective Tissue Graft before Orthodontic treatment; Orthodontic treatment only
Intervention type(s): Procedure; Procedure
Intervention description(s): Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage will be done using sub - epithelial connective tissue graft. Orthodontic treatment will be 3 months following the grafting procedure.; Scaling and root planing will be performed and after resolution of periodontal inflammation, orthodontic treatment will be initiated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment