Chorion Membrane With Photobiostimulation ,Chorion Membrane & SCTG in Treating Isolated RT 2 Recession Defects

NCT06433973 | Not Yet Recruiting DMC

• 1 other identifier: Anisha Kumari Perio 24/36
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Gingival recession (GR) is defined as apical displacement of the gingival margin relative to the cemento-enamel junction, with resultant oral exposure of the root. Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, and these were classifed as Miller class III and IV or Cairo RT2 andRT3 gingival recessions (GRs). Taking all this into account, numerous techniques have been attempted to achieve root coverage of single-rooted tooth, Connective tissue graft presently stands as the benchmark in periodontal plastic surgery, offering excellent predictability and enhanced long-term root coverage. However, its availability is limited and its use often leads to increased patient morbidity.Thus making placental allografts in dentistry a topic of growing interest and recent advancement. It may be hypothesized that CM + LLLT or CM may be used an alternative to SCTG in minimally invasive technique in recession coverage. Hence, this study evaluates root coverage percentages in RT2 gingival defects using a CM with and without photobiostimulation, comparing them to each other and to SCTG- the gold standard control group.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (3)

• Percentage root coverage

  ( Preoperative recession depth) - (Postoperative recession depth) × 100 Preoperative recession depth

  6 months

• Keratinised tissue width

  recorded in mm with a periodontal probe, from the crest of gingival margin to the mucogingival junction.

  6 months

• interproximal Clinical attachment level (iCAL)

  recorded in mm with a periodontal probe from the cemento enamel junction to the base of the pocket by inserting the periodontal probe at the interproximal region

  6 months

Secondary Outcomes (7)

• Bleeding on probing (BOP)

  6 months

• Buccal Clinical attachment level

  6 months

• change in Gingival thickness

  6 months

• Recession depth

  6 months

• Recession width

  6 months

Study Arms (3)

Test group 1 - CM+LLLT+VISTA

EXPERIMENTAL

After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. Photobiostimulation will be done using of diode laser.

Procedure: Test group 1 - CM+LLLT+VISTA

Test group 2 - CM+VISTA

EXPERIMENTAL

After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique.

Procedure: Test group 2 - CM+VISTA

Control group - SCTG+VISTA

OTHER

Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique.

Procedure: Control group - SCTG+VISTA

Interventions

Test group 1 - CM+LLLT+VISTA PROCEDURE

After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. LLLT will be applied on the site for 10 sec.

Test group 1 - CM+LLLT+VISTA

Test group 2 - CM+VISTA PROCEDURE

After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts. Adequate size of CM will be trimmed and applied over the recession defect using minimally invasive technique and secured with sutures.

Test group 2 - CM+VISTA

Control group - SCTG+VISTA PROCEDURE

Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique.

Control group - SCTG+VISTA

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Millers class3or RT2 isolated recession defects in labial mandibular anterior teeth region.
• Systemically healthy individuals.
• Absence of clinical tooth mobility.
• Age \>18 years old.
• A full mouth plaque index \< 20%
• Patient showing adequate compliance and willing to participate in the study.

You may not qualify if:

• Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
• patient with active periodontal disease
• smokers and tobacco users
• mal-alingned lower anteriors.
• patients who had already undergone root coverage procedure on the selected site.
• pregnant and lactating females
• Involved tooth with trauma from occlusion.
• Involved tooth with prosthesis.
• Endodontically involved/ RCT treated tooth
• Tooth with cervical abrasion / undetectable CEJ/ carious.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

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

• Anisha Kumari, BDS

  PGIDS, Rohtak

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shikha Tewari, MDS

CONTACT

8708249475; drshikhatewari@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: June 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)