Early Versus Delayed Orthodontic Treatment After Periodontal Surgery on Periodontal Health in Periodontally Compromised Patients

NCT ID: NCT05466253

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2022-12-20

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.

Conditions

Periodontitis, Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1 EARLY

In experimental group Orthodontic treatment will be started (early) 10 days after periodontal surgery

Group Type: EXPERIMENTAL

Fixed Orthodontic treatment

Intervention Type: PROCEDURE

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.

Group 2 DELAYED

control group will receive orthodontic intervention(delayed) 3 months after periodontal surgery

Group Type: EXPERIMENTAL

Fixed Orthodontic treatment

Intervention Type: PROCEDURE

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.

Interventions

Fixed Orthodontic treatment

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, India

Countries

India

Other Identifiers

PGIDS/BHRC/21/20/ANUNAY

Identifier Type: -

Identifier Source: org_study_id