Improving the condition of gums and jaw bone before correction of crooked teeth by wire treatment

Phase 3

Recruiting

• Conditions: Chronic gingivitis,

• Registration Number: CTRI/2023/11/059519
• Lead Sponsor: SCB Dental College and Hospital

Brief Summary

The relationship between orthodontic tooth movement and the periodontium is dynamic and co-dependent. The mandibular anterior region often presents challenging mucogingival conditions such as reduced vestibular depth, decreased width and thickness of keratinized tissue, and aberrant frenum, presence of fenestration and dehiscences.2 These conditions significantly increase the risk of developing mucogingival problems. In American academy of Periodontology 2018 Classification of Periodontal and Peri-Implant Diseases and Conditions, a new term, periodontal phenotype, was adopted to describe the combination of gingival phenotype (three-dimensional gingival volume) and bone morphotype (thickness of the bone plate).3The periodontal phenotype, plays a crucial role in the development of gingival recessions following orthodontic tooth movement. To mitigate the risk of gingival recession in patients with thin gingival or bone thickness prior to orthodontic treatment, phenotype modification therapy (PhMT) using bone grafts and/or soft tissue grafts has been proposed. The aim is to assess and compare the periodontal status of patients undergoing orthodontic treatment with and without phenotype modification therapy (PhMT). 30 subjects with thin gingival biotype, clinical evidence of fenestration and dehiscence (presence of washboard gingiva) with /without shallow vestibule, decreased width of keratinised tissue, gingival recession undergoing orthodontic treatment will be randomly allotted to test group ( orthodontic treatment post PhMT) and control group ( orthodontic treatment only). The test group subjects will undergo PhMT using bone graft, and/or soft tissue and /or connective tissue graft along with coronally advanced flap. The alveolar bone thickness (labial and lingual region) in the mandibular anterior teeth will be measured using Cone-beam computed tomography (CBCT) at baseline (before periodontal surgery) and 6 months post orthodontic treatment. Plaque and gingival index will be scored at baseline, prior to surgery and subsequently at every post-surgical visit during the course of orthodontic treatment. At each of these visits, gingival width and thickness, recession depth and width (if present), probing depth, clinical attachment level, vestibular depth will also be measured.  Supra gingival polishing at each of these visits may be done as required. In addition a healing index for the donor site at 1 week, 2 weeks, 3 weeks, and 4 weeks and an esthetic score for the recipient site at six months post-surgery and post orthodontic treatment will be recorded.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-08-11
• Study Start: 2023-12-15

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subjects with thin gingival biotype, shallow vestibule, presence of fenestration and dehiscence, decreased width of keratinised tissue with ≤2mm gingival recession undergoing orthodontic treatment.
• Subjects without any active periodontal disease.

Exclusion Criteria

• Smoker or tobacco chewing subjects.
• Pregnant subjects and subjects with systemic diseases or taking drugs which might influence healing after periodontal surgery.
• Patients with active periodontal disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure and compare width, thickness of keratinised gingiva and bone thickness before and after orthodontic treatment in patients with and without PhMT.	Baseline, 6 months after surgery, post orthodontic treatment

Secondary Outcome Measures

Name	Time	Method
Plaque and gingival index,	recession depth and width (if present), probing depth, clinical attachment level, vestibular depth

Trial Locations

Locations (1)

SCB Dental College and Hospital; 🇮🇳 Cuttack, ORISSA, India

SCB Dental College and Hospital

🇮🇳Cuttack, ORISSA, India

Neelima Katti

Principal investigator

9337613446

kattineelima@gmail.com