Effect of Orthodontic Treatment on the Stability of Pre-Orthodontic Recession Coverage

NCT03886051 | Completed DMC

• 1 other identifier: perioloveleena
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• recession depth

  • Recession depth (REC) recorded in mm from the cementoenamel junction to the crest of the gingival margin at the deepest point

  approximate 14 months

Study Arms (2)

test group

EXPERIMENTAL

Connective Tissue Graft before Orthodontic treatment

Procedure: Connective Tissue Graft before Orthodontic treatment

control group

ACTIVE COMPARATOR

Orthodontic treatment only

Procedure: Orthodontic treatment only

Interventions

Connective Tissue Graft before Orthodontic treatment PROCEDURE

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.

test group

Orthodontic treatment only PROCEDURE

Scaling and root planing will be performed and after resolution of periodontal inflammation, orthodontic treatment will be initiated.

control group

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 16-25 yrs.
• Anterior tooth displaying Miller's class III gingival recession.
• Gingival recession depth ≥ 2mm
• Arch length tooth material discrepancy ≤ 4 mm in anterior teeth which can be treated orthodontically without indication for planned extraction.
• At the time of enrollment, the patient not having trauma from occlusion.
• Presence of clinically identifiable cementoenamel junction.
• Patient demonstrating compliance for maintaining good oral hygiene after Phase I treatment.

You may not qualify if:

• Patient having any systemic illness (such as diabetes, hyperthyroidism, autoimmune diseases, etc.) that is known to affect the periodontium or outcome of periodontal treatment.
• Aggressive Periodontitis
• Patients taking medications such as corticosteroids or calcium channel blockers, which are known to interfere with periodontal wound healing or patients on long-term NSAIDS treatment.
• Patients allergic to medication (local anaesthetic, antibiotic, NSAID).
• Pregnant or lactating women.
• History of recent periodontal treatment within 6 months prior to the study.
• Teeth Displaying Miller's class III/class IV gingival recession.
• The presence of severe cervical abrasion, erosion or root caries that would require restoration and cervically restored teeth.
• Patients indicated for planned extraction during orthodontic treatment.
• Gingival recession in due to extrusion of the tooth.
• Mobile teeth.
• Non-vital tooth.
• Smokers and tobacco chewers.
• Patients with Oral Piercing.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Shikha Tewari

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• SHIKHA TEWARI

  Post Graduate institute of dental sciences ROHTAK,HARYANA,INDIA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 22, 2019
• Study Start: December 1, 2018
• Primary Completion: March 22, 2020
• Study Completion: March 22, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

IN (1)