Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Furcation Involvement.

NCT06025955 | Recruiting DMC

• 1 other identifier: Nehaperio123
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The reduced rate of success experienced in the treatment of Furcation involvement (FI) seems to result from the incomplete removal of subgingival plaque and calculus in the interradicular area owing to the peculiar anatomy of the furcation space. Regarding the therapeutic approach, although FI treated with a conservative approach may not yield the same satisfactory results as single rooted teeth; it has been shown that teeth with FI have a remarkable survival rate following conservative treatment in patients demonstrating a satisfactory plaque control. Minimally invasive techniques aim to retain the preoperative gingival architecture, create a minimal wound and gently handle soft and hard tissues. It becomes imperative to see the differences in clinical, and patient centered outcomes of minimally invasive non- surgical versus surgical technique in the management of furcation involvement in mandibulae molar.

Conditions

Furcation Defects; Open Flap Debridement; Periodontal Diseases

Outcome Measures

Primary Outcomes (2)

• change in horizontal clinical attachment level (HCAL)

  change in horizontal clinical attachment level (HCAL) of the furcation as assessed

  3 months

• change in horizontal clinical attachment level (HCAL)

  change in horizontal clinical attachment level (HCAL) of the furcation as assessed

  6 months

Secondary Outcomes (6)

• changes in vertical probing depth of the furcation

  3 months

• changes in vertical probing depth of the furcation

  6 months

• change in changes vertical clinical attachment level of furcation

  3 months

• change in vertical clinical attachment level of furcation

  6 months

• probing pocket depth (PPD)reduction

  3 months

Study Arms (2)

minimally invasive non surgical therapy

EXPERIMENTAL

Experimental sites designated to receive non-surgical treatment will be submitted to careful subgingival debridement using curettes and ultrasonic device using 3.5 x magnification.

Procedure: minimally invasive non- surgical therapy

open flap debridement

ACTIVE COMPARATOR

Surgical technique will be used and the full-thickness flap will be minimally elevated. The granulation soft tissue will be dissected with a blade and carefully removed with curettes.

Procedure: open flap debridement

Interventions

minimally invasive non- surgical therapy PROCEDURE

hand and ultrasonic instrumentation will be done

minimally invasive non surgical therapy

open flap debridement PROCEDURE

flap surgery will be done

open flap debridement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy patients with diagnosis of generalized stage 3 periodontitis (Grade A or B) with at least one mandibular molar with FI (Degree 1 or 2-according to Hamp, 1975 and Subclass A or B- according to Tarnow and Fletcher, 1984), interproximal bone coronal to the furcation fornix and root trunk length ≤ cervical two thirds of the root length as measured on a periapical radiograph.
• Full mouth plaque score \< 30% after initial therapy
• Full mouth bleeding score \< 30% after initial therapy
• Having undergone a course of subgingival instrumentation in the past three months

You may not qualify if:

• Pregnant or lactating females
• Requiring antibiotic premedication
• Received antibiotic treatment in the previous 3 months
• Previous periodontal surgery in the last 1 year
• Smokers
• Pulpal or periapical pathology
• Third molar
• Non restorable tooth
• Trauma from occlusion

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Furcation Defects; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Neha AGGARWAL, BDS

  PT BD SHARMA UHSR HARAYANA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DR. RITIKA ARORA, MDS

CONTACT

9810734445; drritika44@gmail.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: August 7, 2023
• First Posted: September 6, 2023
• Study Start: September 15, 2023
• Primary Completion: November 30, 2024
• Study Completion: February 28, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)