search
Back to results

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

Primary Purpose

Furcation Defects, Open Flap Debridement, Periodontal Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
minimally invasive non- surgical therapy
open flap debridement
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Furcation Defects

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Post Graduate Institute of Dental Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

minimally invasive non surgical therapy

open flap debridement

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 7, 2023
Last Updated
September 1, 2023
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
search

1. Study Identification

Unique Protocol Identification Number
NCT06025955
Brief Title
Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Furcation Involvement.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Furcation Defects, Open Flap Debridement, Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
minimally invasive non surgical therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
open flap debridement
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
minimally invasive non- surgical therapy
Intervention Description
hand and ultrasonic instrumentation will be done
Intervention Type
Procedure
Intervention Name(s)
open flap debridement
Intervention Description
flap surgery will be done
Primary Outcome Measure Information:
Title
change in horizontal clinical attachment level (HCAL)
Description
change in horizontal clinical attachment level (HCAL) of the furcation as assessed
Time Frame
3 months
Title
change in horizontal clinical attachment level (HCAL)
Description
change in horizontal clinical attachment level (HCAL) of the furcation as assessed
Time Frame
6 months
Secondary Outcome Measure Information:
Title
changes in vertical probing depth of the furcation
Description
vertical probing depth will be assessed using UNC 15probe
Time Frame
3 months
Title
changes in vertical probing depth of the furcation
Description
vertical probing depth will be assessed using UNC 15probe
Time Frame
6 months
Title
change in changes vertical clinical attachment level of furcation
Description
change clinical vertical attachment will be assessed using UNC 15 probe
Time Frame
3 months
Title
change in vertical clinical attachment level of furcation
Description
change in vertical clinical attachment level of furcation will be assessed using UNC 15 probe
Time Frame
6 months
Title
probing pocket depth (PPD)reduction
Description
probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites
Time Frame
3 months
Title
probing pocket depth (PPD)reduction
Description
probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DR. RITIKA ARORA, MDS
Phone
9810734445
Email
drritika44@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha AGGARWAL, BDS
Organizational Affiliation
PT BD SHARMA UHSR HARAYANA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Post Graduate Institute of Dental Sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs