PeriodontitisFibReORS vs AFNCT06663202
Osseous Resective Surgery Vs Conservative Surgery with or Without Papilla Preservation Technique
A study testing Fiber retention osseous resective surgery, Papilla preservation flap and Widman flap procedure in people with Periodontitis, run by University of Turin, Italy.
Trial summary
The primary aim of the study is to evaluate the efficacy of either fibre retention osseous resective surgery (FibReORS) or conservative surgery with or without PPT in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontitis
- What is being tested?
- Fiber retention osseous resective surgery, Papilla preservation flap and Widman flap procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of stage III/IV periodontitis.
- Completed steps I-II periodontal therapy at least 6 weeks before.
- Full Mouth Plaque Score less than 15% at re-evaluation.
- Full Mouth Bleeding Score less than 15% at re-evaluation.
- Posterior sextant with residual PPD ≥ 6 mm at ≥ 2 natural teeth (third molars excluded).
- Signed informed consent.
Who cannot join
- Compromised general health which contraindicates the study procedures (ASA III-VI patients).
- Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
- Pregnant or nursing women.
- Presence of tooth mobility ≥ class 2.
- Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
- Presence of deep infrabony defects (≥ 3 mm) at the involved sextant.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Giacomo Baima contact
About this study
Official title: Fibre-Retention Osseous Resective Surgery (FibReORS) Vs Conservative Surgery with or Without Papilla Preservation Technique for the Treatment of Residual Pockets: a 5-year Randomized Clinical Trial
The primary aim of the study is to evaluate the efficacy of either fibre retention osseous resective surgery (FibReORS) or conservative surgery with or without PPT in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). Moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.
- Conditions
- Periodontitis
- Being tested
- Fiber retention osseous resective surgery, Papilla preservation flap, Widman flap procedure
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber retention osseous resective surgeryProcedure or surgery
At the buccal and lingual sides, paramarginal or intrasulcular incisions will be made based on probing pocket depth values and the width of keratinised tissues.
Thinned palatal flap technique will be performed on the palatal side. Bone remodelling will be carefully made using manual or rotary instruments in order to reshape positive attached fibres/bony architecture utilising the FibReORS technique, great attention will be made to distinguish between inflammatory granulation tissue and connective tissue fibres attached to root cementum by means of periodontal probe. Flaps will be positioned at the level of the alveolar crest without tension.
Papilla preservation flapProcedure or surgery
Surgical access will be obtained using modified papilla preservation techniques and when interproximal space is narrow (less than 3mm in width) incision will be made using the simplified papilla preservation flap. Both flaps buccal and lingual/palatal will be elevated in any case to allow root surface cleaning and defects debridement under direct vision. Minimally invasive flap elevation preventing to damage inter proximal tissues with the preservation of the papilla. Defects debridement with mini-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Flaps will be positioned at the pre-surgical level without any tension. Monofilament non-resorbable 5-0 e-PTFE suturing material will be used. Suturing will be performed with external vertical mattress sutures to achieve primary intention closure.
Widman flap procedureProcedure or surgery
Surgical access will be obtained using the modified Widman flap technique. Intrasulcular incision will be done on both buccal and lingual/palatal sides without attempting to preserve the interdental tissues and interdental tissues will be removed. Both flaps buccal and lingual/palatal will be elevated at full thickness in any case to allow root surface cleaning and defects debridement under direct vision, a vertical releasing incision could be made when needed.
Defects debridement with mini-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Flaps will be positioned at the level of the alveolar crest without tension. Monofilament nonresorbable 5 - 0 e/PTFE suturing material will be used. Suturing will be performed with single interrupted sutures.
| Study group | Role | What they receive |
|---|---|---|
| Fiber Retention Osseous Resective Surgery | Experimental | Paramarginal incisions both on buccal and lingual/palatal sides with bone remodelling preserving the supracrestal fibers Receives: Procedure: Fiber retention osseous resective surgery |
| Papilla preservation flap | Active comparator | Access flap for open flap debridement using intrasulcular incisions and papilla preservation approaches to preserve the entire interdental tissues Receives: Procedure: Papilla preservation flap |
| Conventional surgery | Active comparator | Access flap for open flap debridement using a conventional modified Widman flap procedure Receives: Procedure: Widman flap procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket closure
Defined as probing pocket depth (PPD) of 3 mm or less or PPD of 4 mm with the absence of Bleeding on Probing in sites with PPD equal or more than 6 mm at baseline.
Measured: 5 years
Secondary outcomes (5)
Mean Probing Pocket Depth changes
Defined as the mean changes in Probing pocket depth (distance in mm from the gingival margin to the bottom of the probable sulcus) at the involved sextant with respect to baseline.
Measured: 5 Years
Mean Clinical Attachment Level changes
Defined as the mean changes in Clinical Attachment Level (distance in mm from the Cemento Enamel Junction to the bottom of the probable sulcus) at the involved sextant with respect to baseline.
Measured: 5 years
Mean recession changes
Defined as the changes in recession (distance in mm from cemento enamel junction to the gingival margin).
Measured: 5 years
Tooth Retention
Number of teeth in the treated sextant present at the last follow-up evaluation.
Measured: 5 years
Number of instrumentation re-intervention
Number of re-instrumentation interventions during supportive periodontal therapy performed at sites with incomplete outcome.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start15 Nov 2024 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Aimetti, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663202
- Sponsor's protocol ID
- TurinPerioSurgery
- Acronym
- FibReORS vs AF
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibre-Retention Osseous Resective Surgery (FibReORS) Vs Conservative Surgery with or Without Papilla Preservation Technique for the Treatment of Residual Pockets: a 5-year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06663202
- Acronym / sponsor ID
- FibReORS vs AF / TurinPerioSurgery
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 29 Oct 2024 (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 primary aim of the study is to evaluate the efficacy of either fibre retention osseous resective surgery (FibReORS) or conservative surgery with or without PPT in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). Moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fiber Retention Osseous Resective Surgery | Experimental | Procedure: Fiber retention osseous resective surgeryParamarginal incisions both on buccal and lingual/palatal sides with bone remodelling preserving the supracrestal fibers |
| Papilla preservation flap | Active comparator | Procedure: Papilla preservation flapAccess flap for open flap debridement using intrasulcular incisions and papilla preservation approaches to preserve the entire interdental tissues |
| Conventional surgery | Active comparator | Procedure: Widman flap procedureAccess flap for open flap debridement using a conventional modified Widman flap procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of stage III/IV periodontitis.
- Completed steps I-II periodontal therapy at least 6 weeks before.
- Full Mouth Plaque Score less than 15% at re-evaluation.
- Full Mouth Bleeding Score less than 15% at re-evaluation.
- Posterior sextant with residual PPD ≥ 6 mm at ≥ 2 natural teeth (third molars excluded).
Key exclusion criteria (6 listed)
- Compromised general health which contraindicates the study procedures (ASA III-VI patients).
- Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
- Pregnant or nursing women.
- Presence of tooth mobility ≥ class 2.
- Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
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 |
|---|---|---|
| Fiber retention osseous resective surgeryAt the buccal and lingual sides, paramarginal or intrasulcular incisions will be made based on probing pocket depth values and the width of keratinised tissues. Thinned palatal flap technique will be performed on the palatal side. Bone remodelling will be carefully made using manual or rotary instruments in order to reshape positive attached fibres/bony architecture utilising the FibReORS technique, great attention will be made to distinguish between inflammatory granulation tissue and connective tissue fibres attached to root cementum by means of periodontal probe. Flaps will be positioned at the level of the alveolar crest without tension. | Procedure or surgery | Fiber Retention Osseous Resective Surgery |
| Papilla preservation flapSurgical access will be obtained using modified papilla preservation techniques and when interproximal space is narrow (less than 3mm in width) incision will be made using the simplified papilla preservation flap. Both flaps buccal and lingual/palatal will be elevated in any case to allow root surface cleaning and defects debridement under direct vision. Minimally invasive flap elevation preventing to damage inter proximal tissues with the preservation of the papilla. Defects debridement with mini-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Flaps will be positioned at the pre-surgical level without any tension. Monofilament non-resorbable 5-0 e-PTFE suturing material will be used. Suturing will be performed with external vertical mattress sutures to achieve primary intention closure. | Procedure or surgery | Papilla preservation flap |
| Widman flap procedureSurgical access will be obtained using the modified Widman flap technique. Intrasulcular incision will be done on both buccal and lingual/palatal sides without attempting to preserve the interdental tissues and interdental tissues will be removed. Both flaps buccal and lingual/palatal will be elevated at full thickness in any case to allow root surface cleaning and defects debridement under direct vision, a vertical releasing incision could be made when needed. Defects debridement with mini-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Flaps will be positioned at the level of the alveolar crest without tension. Monofilament nonresorbable 5 - 0 e/PTFE suturing material will be used. Suturing will be performed with single interrupted sutures. | Procedure or surgery | Conventional surgery |
Primary outcome
Pocket closure
Time frame: 5 years
Defined as probing pocket depth (PPD) of 3 mm or less or PPD of 4 mm with the absence of Bleeding on Probing in sites with PPD equal or more than 6 mm at baseline.
5 secondary outcomes
Mean Probing Pocket Depth changes
Time frame: 5 Years
Mean Clinical Attachment Level changes
Time frame: 5 years
Mean recession changes
Time frame: 5 years
Tooth Retention
Time frame: 5 years
Number of instrumentation re-intervention
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
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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.
Giacomo Baima contact
Questions about this trial
What is this clinical trial studying?
A study testing Fiber retention osseous resective surgery, Papilla preservation flap and Widman flap procedure in people with Periodontitis, run by University of Turin, Italy.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Aimetti, Prof. (011 6331546, mario.aimetti@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket closure (time frame: 5 years). 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 31 Oct 2024; AzTrials last refreshed its copy on 3 Nov 2026.