PeriodontitisNCT06123000
Modified Widman Flap vs Fibre Retention Osseous Resective Surgery
A study testing Modified Widman Flap (MWF) and Fiber Retention Osseous Resective Surgery (FibReORS) in people with Periodontitis and Periodontal Pocket, run by University of Florence at 1 site in Italy.
Trial summary
The treatment of periodontitis should be carried out in an incremental manner, first by achieving adequate patient's oral hygiene practices and risk factor control during the first step of therapy and then, during the second step of therapy, by professional elimination (reduction) of supra and subgingival biofilm and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Periodontal Pocket, Periodontal Attachment Loss
- What is being tested?
- Modified Widman Flap (MWF) and Fiber Retention Osseous Resective Surgery (FibReORS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 21 Oct 2024to 21 Oct 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Patients affected by periodontitis;
- No systemic disease or pregnancy;
- No systemic antibiotic therapy in 6 months preceding the enrollment;
- Smoking ≤ 20 cigarettes/day;
- Full-mouth plaque score (FMPS) and full- mouth bleeding score (FMBS) ≤ 15%;
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- Residual periodontal pocket ≥5 mm with bleeding on probing at posterior natural teeth;
- Experimental pocket associated with a detectable infrabony defect ≤ 3mm at x-ray;
- No history of periodontal surgery at the experimental site.
Who cannot join
- Undetectable cemento-enamel junction (CEJ) at experimental teeth;
- Severe furcation involvement (class II and III);
- Abutment for prosthetic rehabilitation;
- Periodontal Pockets associated with infrabony defect >3 mm;
- Horizontal bone loss higher than 1/3 of the root length at experimental teeth;
- Severe tooth mobility at baseline (class 2 or 3).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Università degli Studi di Firenze
Florence, FI, 50134
Luigi Barbato, Dr., 3299457556 ext. +39, luigi.barbato@unifi.it
About this study
Official title: Modified Widman Flap (MWF) vs Fibre Retention Osseous Resective Surgery (FibReORS): A Randomized, Controlled, Clinical Trial.
The treatment of periodontitis should be carried out in an incremental manner, first by achieving adequate patient's oral hygiene practices and risk factor control during the first step of therapy and then, during the second step of therapy, by professional elimination (reduction) of supra and subgingival biofilm and calculus.
If the endpoints of therapy (no periodontal pockets >4 mm with bleeding on probing, BoP, or deep pockets ≥5 mm) have not been achieved, the third step of therapy should be implemented.
Read more
In fact, residual pockets following step 1 and 2 of periodontal treatment are associated with increased risk of periodontal disease progression in the long-term as reported by Claffey \& Egelberg in1995. Residual probing depth (PPD) ≥5 mm after active therapy is a risk factor for disease progression and tooth loss during supportive periodontal therapy (SPT), suggesting that additional treatment of residual pockets is strongly recommended.
The third step of treatment includes the following interventions: repeated subgingival instrumentation, access flap periodontal surgery, resective periodontal surgery, regenerative periodontal surgery.
In case of residual pockets associated with shallow-moderate infrabony defects at posterior teeth, where both regenerative therapy and non-surgical re-instrumentation are usually not indicated, access flap procedures (i.e., the Modified Widman Flap, MWF) and the Osseous Resective Surgery (ORS) are considered two of the most viable options.
The value of these surgical techniques has been tested over the years by different clinical trials, and the choice of a surgical approach still relies mainly on the decision-making process of the surgeon, since the long-term outcomes of the different periodontal surgical procedures are similar, as highlighted by a recent systematic review.
Nevertheless, one the main criticism that have been moved against ORS, lies on the fact that the side effects (i.e., gingival recessions) seem to be more severe for ORS surgery, when compared with MWF.
In the early 2000s, Carnevale proposed the Fibre Retention Osseous Resective Surgery (FibReORS), an approach that leads to a more conservative bone resection to eliminate infrabony defects and establish a positive bony architecture than the conventional ORS. Indeed, this one, based on the histological findings by Gargiulo et al. (1961), uses the level of the connective tissue attachment - rather than the bottom of the osseous defect - as the reference to apply the principles of ORS.
Two randomized clinical trials demonstrated that FibReORS is similarly effective as ORS for PPD reduction with less final gingival recessions (REC), clinical attachment loss (CAL) patient morbidity.
Nevertheless, no studies have ever directly compared FibreORS with MWF. Therefore, the aim of this randomized clinical trial (RCT) is to compare the efficacy of FibReORS versus MWF in the treatment of periodontal pockets associated with infrabony defects ≤3 mm at posterior natural teeth.
Objectives
The experimental hypothesis is:
FibReORS is superior to MWF in achieving PPD closure (PPD <4 mm without BoP) at posterior teeth associated with shallow-moderate infrabony defects.
- Being tested
- Modified Widman Flap (MWF), Fiber Retention Osseous Resective Surgery (FibReORS)
- Medical subject headings
- Periodontitis, Periodontal Pocket, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Widman Flap (MWF)Procedure or surgery
At buccal and lingual/palatal side, a full thickness incision parallel to the long axis of the tooth will be performed. In case of buccal or lingual pockets deeper than 2 mm, this initial incision will be placed approximately 1 mm apically to the free gingival margin. All soft tissues will be removed from the bony surface of intrabony defects. In case of incomplete adaptation between the flaps and the teeth or between the buccal and lingual flaps, the flaps will be thinned, and an amount of bone removal will be performed. Only osteoplasty will be allowed, while these patients will not receive ostectomy.
Fiber Retention Osseous Resective Surgery (FibReORS)Procedure or surgery
At the buccal sites, internally beveled incisions will be positioned at intra-sulcular or extra-sulcular level based on the apico-coronal dimension of the keratinized tissue. A split thickness flap beyond the MGJ will be then elevated. Vertical releasing incisions will be used to augment surgical access as needed. At lingual site split-full-thickness flap was used positioning an extra-sulcular internally beveled primary incision, while at the palatal area, the thinned palatal flap technique will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Modified Widman Flap (MWF) | Active comparator | At buccal and lingual/palatal side, a full thickness incision parallel to the long axis of the tooth will be performed. In case of buccal or lingual pockets deeper than 2 mm, this initial incision will be placed approximately 1 mm apically to the free gingival margin. All soft tissues will be removed from the bony surface of intrabony defects. In case of incomplete adaptation between the flaps and the teeth or between the buccal and lingual flaps, the flaps will be thinned, and an amount of bone removal will be performed. Only osteoplasty will be allowed, while these patients will not receive ostectomy. Receives: Procedure: Modified Widman Flap (MWF) |
| Fiber Retention Osseous Resective Surgery (FibReORS) | Experimental | At the buccal sites, internally beveled incisions will be positioned at intra-sulcular or extra-sulcular level based on the apico-coronal dimension of the keratinized tissue. A split thickness flap beyond the MGJ will be then elevated. Vertical releasing incisions will be used to augment surgical access as needed. At lingual site split-full-thickness flap was used positioning an extra-sulcular internally beveled primary incision, while at the palatal area, the thinned palatal flap technique will be performed Receives: Procedure: Fiber Retention Osseous Resective Surgery (FibReORS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Pocket Closure
Distance between the tip of a periodontal probe and the gingival margin < 4 mm, without bleeding.
Measured: Six months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start21 Oct 2024
- Primary completion21 Oct 2025 (estimated)
- Study completion21 Oct 2026 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Barbato, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123000
- Sponsor's protocol ID
- MWF vs FibReORS
- Status last verified
- Apr 2025
- First submitted
- 2 Nov 2023
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Widman Flap (MWF) vs Fibre Retention Osseous Resective Surgery (FibReORS): A Randomized, Controlled, Clinical Trial.
- ClinicalTrials.gov ID
- NCT06123000
- Acronym / sponsor ID
- MWF vs FibReORS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 21 Oct 2025 (estimated)
- Study completion
- 21 Oct 2026 (estimated)
- First posted
- 8 Nov 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 treatment of periodontitis should be carried out in an incremental manner, first by achieving adequate patient's oral hygiene practices and risk factor control during the first step of therapy and then, during the second step of therapy, by professional elimination (reduction) of supra and subgingival biofilm and calculus.
If the endpoints of therapy (no periodontal pockets >4 mm with bleeding on probing, BoP, or deep pockets ≥5 mm) have not been achieved, the third step of therapy should be implemented.
In fact, residual pockets following step 1 and 2 of periodontal treatment are associated with increased risk of periodontal disease progression in the long-term as reported by Claffey \& Egelberg in1995. Residual probing depth (PPD) ≥5 mm after active therapy is a risk factor for disease progression and tooth loss during supportive periodontal therapy (SPT), suggesting that additional treatment of residual pockets is strongly recommended.
The third step of treatment includes the following interventions: repeated subgingival instrumentation, access flap periodontal surgery, resective periodontal surgery, regenerative periodontal surgery.
In case of residual pockets associated with shallow-moderate infrabony defects at posterior teeth, where both regenerative therapy and non-surgical re-instrumentation are usually not indicated, access flap procedures (i.e., the Modified Widman Flap, MWF) and the Osseous Resective Surgery (ORS) are considered two of the most viable options.
The value of these surgical techniques has been tested over the years by different clinical trials, and the choice of a surgical approach still relies mainly on the decision-making process of the surgeon, since the long-term outcomes of the different periodontal surgical procedures are similar, as highlighted by a recent systematic review.
Nevertheless, one the main criticism that have been moved against ORS, lies on the fact that the side effects (i.e., gingival recessions) seem to be more severe for ORS surgery, when compared with MWF.
In the early 2000s, Carnevale proposed the Fibre Retention Osseous Resective Surgery (FibReORS), an approach that leads to a more conservative bone resection to eliminate infrabony defects and establish a positive bony architecture than the conventional ORS. Indeed, this one, based on the histological findings by Gargiulo et al. (1961), uses the level of the connective tissue attachment - rather than the bottom of the osseous defect - as the reference to apply the principles of ORS.
Two randomized clinical trials demonstrated that FibReORS is similarly effective as ORS for PPD reduction with less final gingival recessions (REC), clinical attachment loss (CAL) patient morbidity.
Nevertheless, no studies have ever directly compared FibreORS with MWF. Therefore, the aim of this randomized clinical trial (RCT) is to compare the efficacy of FibReORS versus MWF in the treatment of periodontal pockets associated with infrabony defects ≤3 mm at posterior natural teeth.
Objectives
The experimental hypothesis is:
FibReORS is superior to MWF in achieving PPD closure (PPD <4 mm without BoP) at posterior teeth associated with shallow-moderate infrabony defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Widman Flap (MWF) | Active comparator | Procedure: Modified Widman Flap (MWF)At buccal and lingual/palatal side, a full thickness incision parallel to the long axis of the tooth will be performed. In case of buccal or lingual pockets deeper than 2 mm, this initial incision will be placed approximately 1 mm apically to the free gingival margin. All soft tissues will be removed from the bony surface of intrabony defects. In case of incomplete adaptation between the flaps and the teeth or between the buccal and lingual flaps, the flaps will be thinned, and an amount of bone removal will be performed. Only osteoplasty will be allowed, while these patients will not receive ostectomy. |
| Fiber Retention Osseous Resective Surgery (FibReORS) | Experimental | Procedure: Fiber Retention Osseous Resective Surgery (FibReORS)At the buccal sites, internally beveled incisions will be positioned at intra-sulcular or extra-sulcular level based on the apico-coronal dimension of the keratinized tissue. A split thickness flap beyond the MGJ will be then elevated. Vertical releasing incisions will be used to augment surgical access as needed. At lingual site split-full-thickness flap was used positioning an extra-sulcular internally beveled primary incision, while at the palatal area, the thinned palatal flap technique will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years;
- Patients affected by periodontitis;
- No systemic disease or pregnancy;
- No systemic antibiotic therapy in 6 months preceding the enrollment;
- Smoking ≤ 20 cigarettes/day;
Key exclusion criteria (6 listed)
- Undetectable cemento-enamel junction (CEJ) at experimental teeth;
- Severe furcation involvement (class II and III);
- Abutment for prosthetic rehabilitation;
- Periodontal Pockets associated with infrabony defect >3 mm;
- Horizontal bone loss higher than 1/3 of the root length at experimental 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 |
|---|---|---|
| Modified Widman Flap (MWF)At buccal and lingual/palatal side, a full thickness incision parallel to the long axis of the tooth will be performed. In case of buccal or lingual pockets deeper than 2 mm, this initial incision will be placed approximately 1 mm apically to the free gingival margin. All soft tissues will be removed from the bony surface of intrabony defects. In case of incomplete adaptation between the flaps and the teeth or between the buccal and lingual flaps, the flaps will be thinned, and an amount of bone removal will be performed. Only osteoplasty will be allowed, while these patients will not receive ostectomy. | Procedure or surgery | Modified Widman Flap (MWF) |
| Fiber Retention Osseous Resective Surgery (FibReORS)At the buccal sites, internally beveled incisions will be positioned at intra-sulcular or extra-sulcular level based on the apico-coronal dimension of the keratinized tissue. A split thickness flap beyond the MGJ will be then elevated. Vertical releasing incisions will be used to augment surgical access as needed. At lingual site split-full-thickness flap was used positioning an extra-sulcular internally beveled primary incision, while at the palatal area, the thinned palatal flap technique will be performed. | Procedure or surgery | Fiber Retention Osseous Resective Surgery (FibReORS) |
Primary outcome
Periodontal Pocket Closure
Time frame: Six months after the procedure
Distance between the tip of a periodontal probe and the gingival margin < 4 mm, without bleeding.
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 10 Apr 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Widman Flap (MWF) and Fiber Retention Osseous Resective Surgery (FibReORS) in people with Periodontitis and Periodontal Pocket, run by University of Florence at 1 site in 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 9 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: looking for participants now, as of the sponsor's last update on 10 Apr 2025. 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 Italy. 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?
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 Luigi Barbato, Dr. (3299457556 ext. +39, luigi.barbato@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal Pocket Closure (time frame: Six months after the procedure). 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 10 Apr 2025.