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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06025955
Enrollment
44
Registered
2023-09-06
Start date
2023-09-15
Completion date
2025-02-28
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Furcation Defects, Open Flap Debridement, Periodontal Diseases

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 .

Interventions

PROCEDUREminimally invasive non- surgical therapy

hand and ultrasonic instrumentation will be done

PROCEDUREopen flap debridement

flap surgery will be done

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
change in horizontal clinical attachment level (HCAL)3 monthschange in horizontal clinical attachment level (HCAL) of the furcation as assessed

Secondary

MeasureTime frameDescription
changes in vertical probing depth of the furcation3 monthsvertical probing depth will be assessed using UNC 15probe
change in changes vertical clinical attachment level of furcation3 monthschange clinical vertical attachment will be assessed using UNC 15 probe
change in vertical clinical attachment level of furcation6 monthschange in vertical clinical attachment level of furcation will be assessed using UNC 15 probe
probing pocket depth (PPD)reduction3 monthsprobing pocket depth (PPD)reduction will be calculated around the molar at 6 sites

Countries

India

Contacts

Primary ContactDR. RITIKA ARORA, MDS
drritika44@gmail.com9810734445

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026