Effect of Orthodontic Treatment on Periodontally Compromised Dentition- Randomised Control Trial

Not Applicable

• Conditions: Periodontal Bone Loss
• Interventions: Procedure: periodontal treatment; Procedure: Periodontal and orthodontic treatment

• Registration Number: NCT03914339
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Brief Summary

The main aim of this prospective, randomized controlled clinical study is to:

• To evaluate and compare the effect of a combined orthodontic -periodontal treatment protocol versus periodontal treatment alone on osseous and non -osseous parameters in periodontally compromised patients.

Detailed Description

All the patients of both the groups will receive a detailed periodontal evaluation and then therapeutic management of patients will be done as per their periodontal requirement. This will include oral hygiene instruction, scaling and root planning and re-evaluation after 2 weeks and periodontal surgical treatment if indicated will be re-evaluated 4-6 weeks. After an observation period of 2 months confirming patient cooperation and their ability to maintain good oral hygiene as well as stability of the periodontal results orthodontic treatment will be started in the test group whereas the control group will be kept on monthly recall for the first 3 months and then every 3 months as per the oral hygiene status requirement of the patient.periodontal charting will be done at every 3 months till finish of treatment and supra gingival scaling will be provided as per requirement in both the groups.Changes in periodontal status in terms of clinical and radiographic parameters will be compared between the groups. cone beam Computed tomography will be taken at the baseline T0 and study end point T2 for assessment of changes in the bone level around maxillary and mandibular teeth

Study Timeline

• Study Start: 2018-12-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-11
• Last Update Submitted: 2019-04-11
• Study First Posted: 2019-04-16
• Last Update Posted: 2019-04-16
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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(≥5 cigarettes∕ day).
• Noncompliance to oral hygiene measures after Phase I therapy.
• Presence of trauma from occlusion (TFO).
• Patients with aggressive periodontitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	periodontal treatment	Eighteen periodontally compromised patients will receive periodontal treatment alone .
Test group	Periodontal and orthodontic treatment	Eighteen periodontally compromised patients who will be given both orthodontic and periodontal treatment .

Primary Outcome Measures

Name	Time	Method
• Alveolar crest bone level	12 months	measured from Cemento- enamel junction to bone crest.
Clinical attachment level (CAL).	12 months	• pocket to cemento- enamel junction .

Trial Locations

Locations (2)

PGIDS; 🇮🇳 Rohtak, Haryana, India

Pgids,Rohtak; 🇮🇳 Rohtak, Haryana, India