ClinicalTrials.gg
RecruitingNCT06025955Updated Feb 26, 2024

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

An interventional study of minimally invasive non- surgical therapy and open flap debridement in Furcation Defects, Open Flap Debridement and Periodontal Diseases, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Recruiting at 1 site in India. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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 .

02

Conditions studied

  • Furcation Defects
  • Open Flap Debridement
  • Periodontal Diseases
03

In context

Furcation Defects

42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.

This study's planned enrollment of 44 is above the median of 27 across 38 interventional studies indexed under Furcation Defects.

Browse Furcation Defects studies →

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 213 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Procedureminimally invasive non- surgical therapy

    hand and ultrasonic instrumentation will be done

  • Procedureopen flap debridement

    flap surgery will be done

06

What researchers measure

Primary outcomes

  1. change in horizontal clinical attachment level (HCAL)

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

    Time frame: 3 months

  2. change in horizontal clinical attachment level (HCAL)

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

    Time frame: 6 months

Secondary outcomes

  1. changes in vertical probing depth of the furcation

    vertical probing depth will be assessed using UNC 15probe

    Time frame: 3 months

  2. changes in vertical probing depth of the furcation

    vertical probing depth will be assessed using UNC 15probe

    Time frame: 6 months

  3. change in changes vertical clinical attachment level of furcation

    change clinical vertical attachment will be assessed using UNC 15 probe

    Time frame: 3 months

  4. change in vertical clinical attachment level of furcation

    change in vertical clinical attachment level of furcation will be assessed using UNC 15 probe

    Time frame: 6 months

  5. probing pocket depth (PPD)reduction

    probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites

    Time frame: 3 months

  6. probing pocket depth (PPD)reduction

    probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2023 (actual). Primary completion is estimated for Nov 2024, 14 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2023
First posted
Sep 6, 2023
StartActual
Sep 15, 2023
Primary completionEst.
Nov 30, 2024
CompletionEst.
Feb 28, 2025
Last update
Feb 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06025955
Responsible party
Sponsor
First posted
Sep 6, 2023
Start date
Sep 15, 2023
Primary completion
Nov 30, 2024 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
Feb 26, 2024

Study contacts

DR. RITIKA ARORA, MDS
Contact
drritika44@gmail.com
9810734445
Neha AGGARWAL, BDS
principal investigator · PT BD SHARMA UHSR HARAYANA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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