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

Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Patients With Furcation Involvement in Mandibular Molars - A Non-inferiority Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases; Furcation Defects; Open Flap Debridement
• Intervention / Treatment: Procedure: minimally invasive non- surgical therapy; Procedure: open flap debridement

Detailed Description

Patients will be recruited from outpatient clinic of Department of Periodontics, PGIDS, Rohtak after screening based on given inclusion and exclusion criteria. after initial session of scaling and root planing patient will be re -elevated at the and of 6 to 8 weeks those having grade 2 furcation involvement in any mandibular molar and meeting other eligibility criteria will be randomly allocated to test group and control group Test group -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.

control group-Surgical technique will be followed with minimally flap reflection and incisions will be performed with papilla preservation techniques. vertical- releasing incisions will not be made, and the full-thickness flap will be minimally elevated. The granulation soft tissue will be dissected with a blade and carefully removed with curettes. The visible calculus will be carefully removed with curettes and an ultrasonic device. The flaps will be re-positioned and sutured and patient follow up 3 to 6 months .

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Ritika Arora, MDS; Phone Number: 9810734445; Email: drritika44@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • Post Graduate Institute of dental sciences
      • Contact: Shikha Tewari, MDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: minimally invasive non surgical therapy; 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; hand and ultrasonic instrumentation will be done
Active Comparator: open flap debridement; 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; flap surgery will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in vertical probing depth of the furcation	vertical probing depth will be assessed using UNC 15probe	3 months
changes in vertical probing depth of the furcation	vertical probing depth will be assessed using UNC 15probe	6 months
change in changes vertical clinical attachment level of furcation	change clinical vertical attachment will be assessed using UNC 15 probe	3 months
change in vertical clinical attachment level of furcation	change in vertical clinical attachment level of furcation will be assessed using UNC 15 probe	6 months
probing pocket depth (PPD)reduction	probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites	3 months
probing pocket depth (PPD)reduction	probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites	6 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Neha AGGARWAL, BDS, PT BD SHARMA UHSR HARAYANA

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases; Furcation Defects
• Other Study ID Numbers: Nehaperio123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No