Furcation DefectsNCT06025955
Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Furcation Involvement.
A study testing minimally invasive non- surgical therapy and open flap debridement in people with Furcation Defects and Open Flap Debridement, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Furcation Defects, Open Flap Debridement, Periodontal Diseases
- What is being tested?
- minimally invasive non- surgical therapy and open flap debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIndia
- Study dates
- 15 Sep 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Third molar
- Non restorable tooth
- Trauma from occlusion
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
Shikha Tewari, MDS
About this study
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
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 .
- Being tested
- minimally invasive non- surgical therapy, open flap debridement
- Medical subject headings
- Furcation Defects, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive non- surgical therapyProcedure or surgery
hand and ultrasonic instrumentation will be done
open flap debridementProcedure or surgery
flap surgery will be done
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: open flap debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in horizontal clinical attachment level (HCAL)
change in horizontal clinical attachment level (HCAL) of the furcation as assessed
Measured: 3 months
change in horizontal clinical attachment level (HCAL)
change in horizontal clinical attachment level (HCAL) of the furcation as assessed
Measured: 6 months
Secondary outcomes (6)
changes in vertical probing depth of the furcation
vertical probing depth will be assessed using UNC 15probe
Measured: 3 months
changes in vertical probing depth of the furcation
vertical probing depth will be assessed using UNC 15probe
Measured: 6 months
change in changes vertical clinical attachment level of furcation
change clinical vertical attachment will be assessed using UNC 15 probe
Measured: 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
Measured: 6 months
probing pocket depth (PPD)reduction
probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites
Measured: 3 months
probing pocket depth (PPD)reduction
probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start15 Sep 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Furcation DefectsStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha AGGARWAL, BDS, Principal investigator, PT BD SHARMA UHSR HARAYANA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025955
- Sponsor's protocol ID
- Nehaperio123
- Status last verified
- Feb 2024
- First submitted
- 7 Aug 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06025955
- Acronym / sponsor ID
- Nehaperio123
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimally invasive non surgical therapy | Experimental | Procedure: minimally invasive non- surgical therapyExperimental sites designated to receive non-surgical treatment will be submitted to careful subgingival debridement using curettes and ultrasonic device using 3.5 x magnification. |
| open flap debridement | Active comparator | Procedure: open flap debridementSurgical 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Pregnant or lactating females
- Requiring antibiotic premedication
- Received antibiotic treatment in the previous 3 months
- Previous periodontal surgery in the last 1 year
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimally invasive non- surgical therapyhand and ultrasonic instrumentation will be done | Procedure or surgery | minimally invasive non surgical therapy |
| open flap debridementflap surgery will be done | Procedure or surgery | open flap debridement |
Primary outcome
change in horizontal clinical attachment level (HCAL)
Time frame: 3 months
change in horizontal clinical attachment level (HCAL) of the furcation as assessed
change in horizontal clinical attachment level (HCAL)
Time frame: 6 months
change in horizontal clinical attachment level (HCAL) of the furcation as assessed
6 secondary outcomes
changes in vertical probing depth of the furcation
Time frame: 3 months
changes in vertical probing depth of the furcation
Time frame: 6 months
change in changes vertical clinical attachment level of furcation
Time frame: 3 months
change in vertical clinical attachment level of furcation
Time frame: 6 months
probing pocket depth (PPD)reduction
Time frame: 3 months
probing pocket depth (PPD)reduction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha AGGARWAL, BDS principal investigator
PT BD SHARMA UHSR HARAYANA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive non- surgical therapy and open flap debridement in people with Furcation Defects and Open Flap Debridement, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DR. RITIKA ARORA, MDS (9810734445, drritika44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in horizontal clinical attachment level (HCAL) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.