Early Versus Delayed Orthodontic Treatment After Periodontal Surgery on Periodontal Health in Periodontally Compromised Patients
Condition: Periodontitis, Adult
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      RESEARCH QUESTION: Will there be a difference in periodontal health of two groups of
      periodontally compromised orthodontic patients with early and delayed start of orthodontic
      treatment after periodontal surgery? Population: Adult orthodontic patients with
      periodontally compromised dentition requiring periodontal surgical management Intervention:
      Fixed orthodontic treatment started 10 days after periodontal surgery Control group: Fixed
      orthodontic treatment started 3 months after periodontal surgery Outcomes: changes in osseous
      (Alveolar bone level) and non-osseous (PI, GI, BOP, PD, CAL) periodontal parameters of the
      teeth involved in periodontal surgery.

      Time frame: One year and four months Study Design: Prospective, randomized controlled
      clinical trial. Specific: Yes Measurable: Yes Achievable: Yes Relevant: Yes Time: One year
      and four months Feasible: Trained staff, infrastructure, time, study design Interesting: A
      new treatment protocol will be investigated. Novel: No study comparing these waiting time
      intervals after periodontal surgery before starting orthodontic treatment.

      Ethical: Yes Relevant: As there is no clarity on waiting period after periodontally surgery
      in periodontally compromised adult patients, this study will be of great help in establishing
      treatment management protocol of such patients.
    

Detailed description: 
      Sample size: The CAL difference of 1.07 mm was considered to be of clinical importance
      between the test and control groups. To be able to detect a clinically meaningful difference
      in mean CAL of 1.0 mm between groups, standard deviation of 1.0 mm, with a power of 80% and
      an alpha-level at 0.05, 15 patients are needed in each group. Accounting for a 20% drop out
      rate 18 patients will be enrolled in each group.

      Method of study: All the patients included in the study will receive a detailed periodontal
      evaluation and all periodontal parameters (osseous and non-osseous) will be recorded at the
      baseline and Phase I periodontal therapy will be provided. This will include oral hygiene
      instruction, scaling and root planning and re-evaluation after one weeks. If the patients are
      able to maintain oral hygiene after preliminary periodontal intervention they will be
      included in further stages of the study. All the patients will receive the indicated
      periodontal surgical treatment. and the patients will then be randomly divided into two
      groups - test group and control group Orthodontic treatment will be started in the test group
      10 days after periodontal surgery whereas the control group will receive orthodontic
      intervention 3 months after periodontal surgery. Supragingival scaling will be done in both
      the groups at 3 month intervals as per requirement.
    

Intervention name(s): Fixed Orthodontic treatment
Intervention type(s): Procedure
Intervention description(s): All the patients will receive the indicated periodontal surgical treatment. and the patients will then be randomly divided into two groups - test group and control group Orthodontic treatment will be started in the test group (EARLY)10 days after periodontal surgery whereas the control group will receive orthodontic intervention (DELAYED) 3 months after periodontal surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All the patients included in the study will receive a detailed periodontal evaluation and all periodontal parameters (osseous and non-osseous) will be recorded at the baseline and Phase I periodontal therapy will be provided. This will include oral hygiene instruction, scaling and root planning and re-evaluation after one weeks. If the patients are able to maintain oral hygiene after preliminary periodontal intervention they will be included in further stages of the study. All the patients will receive the indicated periodontal surgical treatment. and the patients will then be randomly divided into two groups - test group and control group Orthodontic treatment will be started in the test group 10 days after periodontal surgery whereas the control group will receive orthodontic intervention 3 months after periodontal surgery. Supragingival scaling will be done in both the groups at 3 month intervals as per requirement.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ORTHODONTIC PERIODONTAL MANAGEMENT