Clinical trial NCT05466253: Early Versus Delayed Orthodontic Treatment After Periodontal Surgery on Periodontal Health in Periodontally Compromised Patients
Official title: Effects of Early Versus Delayed Orthodontic Treatment After Periodontal Surgery on Periodontal Health in Periodontally Compromised Patients - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis, Adult
Keywords: ORTHODONTIC PERIODONTAL MANAGEMENT
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy patients.
* Adult patients (20-40 years) with periodontally compromised dentition indicated for periodontal surgical intervention.
* Class I malocclusion that needs orthodontic treatment.
* Stage II and Stage III periodontitis according to the criteria of 2017 world workshop.

Exclusion Criteria:

* Systemic illness known to affect the periodontium or outcome of periodontal and orthodontic therapy.
* Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
* Pregnant or lactating women.
* Smokers
* Noncompliance to oral hygiene measures after Phase I therapy.
* Presence of trauma from occlusion (TFO).
* Stage IV periodontitis according to the criteria of 2017 world workshop

Primary outcomes:
measure: Pocket depth
timeFrame: T0 - baseline records, before beginning of any treatment
measure: Pocket depth
timeFrame: T1 - 3 months post periodontal surgery
measure: Pocket depth
timeFrame: T2 - one year after start of orthodontic treatment
measure: alveolar crest bone level
timeFrame: Alveolar bone level will be recorded with the help of CBCT at T0 intervals.T0 - baseline records, before beginning of any treatment,
measure: alveolar crest bone level
timeFrame: Alveolar bone level will be recorded with the help of CBCT at T2 time intervals,T2 - one year after start of orthodontic treatment.
measure: Clinical attachment loss (CAL)
timeFrame: T0 - baseline records, before beginning of any treatment
measure: Clinical attachment loss (CAL)
timeFrame: T1 - 3 months post periodontal surgery
measure: Clinical attachment loss (CAL)
timeFrame: T2 - one year after start of orthodontic treatment
Secondary outcomes:
measure: Bleeding on probing,
timeFrame: T0 - baseline records, before beginning of any treatment
measure: Bleeding on probing,
timeFrame: T1 3 months post periodontal surgery
measure: Bleeding on probing,
timeFrame: T2 - one year after start of orthodontic treatment.
measure: Plaque index
timeFrame: T0 - baseline records, before beginning of any treatment
measure: Plaque index
timeFrame: T1 3 months post periodontal surgery
measure: Plaque index
timeFrame: T2 - one year after start of orthodontic treatment.
measure: Gingival Index
timeFrame: T0 - baseline records, before beginning of any treatment
measure: Gingival Index
timeFrame: T1 3 months post periodontal surgery
measure: Gingival Index
timeFrame: T2 - one year after start of orthodontic treatment.
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
References: