PeriodontitisNCT05140681
Influence of Flap Position Following FibReORS
A study testing FibReORS with apically positioned flap (apical position) and FibReORS with apically positioned flap (crestal position) in people with Periodontitis and Periodontal Diseases, run by University of Turin, Italy at 1 site in Italy.
Trial summary
There is lack of data in literature on keratinized tissue increase after FibReORS in relation to primary flap position. This study has been designed as a split-mouth randomized trial to assess the influence of flap position after FibReORS. 16 patients were recruited and treated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Diseases
- What is being tested?
- FibReORS with apically positioned flap (apical position) and FibReORS with apically positioned flap (crestal position)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2017to 23 Dec 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) diagnosis of severe chronic periodontitis (corresponding to grade III or IV according to the actual classification); 2) good general health; 3) full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 20%; 4) at least two contralateral sextants with residual PDs of > 5 mm and persisting bleeding on probing (BoP) at posterior natural teeth 3 months after the completion of cause-related therapy
Who cannot join
- 1) pregnancy and lactation; 2) smoking > 10 cigarettes/day; 3) intake of antibiotics in the previous 6 months. In addition, teeth with degree II or III mobility, horizontal bone loss higher than 1/3 of the root length or designed as abutment for prosthetic rehabilitation were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Flap Position on Soft Tissue Regrowth, Keratinized Tissue Increase and Postoperative Discomfort Following Fibre Retention Osseous Resective Surgery (FibReORS): a 6-month Split-mouth RCT With Multilevel Analysis.
There is lack of data in literature on keratinized tissue increase after FibReORS in relation to primary flap position. This study has been designed as a split-mouth randomized trial to assess the influence of flap position after FibReORS. 16 patients were recruited and treated. The placement of the flap 2 mm apically to the bone crest instead at the bone level would be a viable approach to increase KT width without delaying wound healing. The extent of post-operative discomfort/pain was not influenced by primary flap position.
- Conditions
- Periodontitis, Periodontal Diseases
- Being tested
- FibReORS with apically positioned flap (apical position), FibReORS with apically positioned flap (crestal position)
- Keywords
- periodontitis, flap position, soft tissue regrowth
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibReORS with apically positioned flap (apical position)Procedure or surgery
Periodontal surgery including flap elevation. root surface scaling, bone remodeling and suture of the flap at 2 mm subcrestal position
FibReORS with apically positioned flap (crestal position)Procedure or surgery
Periodontal surgery including flap elevation. root surface scaling, bone remodeling and suture of the flap at either a crestal position
| Study group | Role | What they receive |
|---|---|---|
| apical group | Experimental | FibReORS with apically flap positioning 2 mm below the bone crest (apical group) Receives: Procedure: FibReORS with apically positioned flap (apical position) |
| Crestal group | Active comparator | FibReORS with apically flap positioning at the level of bone crest (crestal group). Receives: Procedure: FibReORS with apically positioned flap (crestal position) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of soft tissue re-growth after FibReORS
The amount of regrowth is calculated from the position of the tissue at the end of the surgery
Measured: 6 months
Secondary outcomes (1)
Amount of KT increase after FibReORS
The amount of KT increase is calculated from the position of the tissue at the end of the surgery
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 posted1 Dec 2021
- Study start1 Sep 2017
- Primary completion31 Oct 2018
- Study completion23 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
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
- NCT05140681
- Sponsor's protocol ID
- FibReORSTurin
- Status last verified
- Nov 2021
- First submitted
- 18 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piccoli GM, Romano F, Giraudi M, La Bruna N, Citterio F, Mariani GM, Baima G, Aimetti M. Effect of post-surgical flap position on soft tissue regrowth and keratinized tissue increase following fibre retention osseous resective surgery: a 6-month randomized study with multilevel analysis. BMC Oral Health. 2023 Jul 10;23(1):472. doi: 10.1186/s12903-023-03144-2.
PubMed 37430291
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Flap Position on Soft Tissue Regrowth, Keratinized Tissue Increase and Postoperative Discomfort Following Fibre Retention Osseous Resective Surgery (FibReORS): a 6-month Split-mouth RCT With Multilevel Analysis.
- ClinicalTrials.gov ID
- NCT05140681
- Acronym / sponsor ID
- FibReORSTurin
- Conditions
- Periodontitis, Periodontal Diseases
- Keywords
- periodontitis, flap position, soft tissue regrowth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 23 Dec 2018 (actual)
- First posted
- 1 Dec 2021 (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.
There is lack of data in literature on keratinized tissue increase after FibReORS in relation to primary flap position. This study has been designed as a split-mouth randomized trial to assess the influence of flap position after FibReORS. 16 patients were recruited and treated. The placement of the flap 2 mm apically to the bone crest instead at the bone level would be a viable approach to increase KT width without delaying wound healing. The extent of post-operative discomfort/pain was not influenced by primary flap position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| apical group | Experimental | Procedure: FibReORS with apically positioned flap (apical position)FibReORS with apically flap positioning 2 mm below the bone crest (apical group) |
| Crestal group | Active comparator | Procedure: FibReORS with apically positioned flap (crestal position)FibReORS with apically flap positioning at the level of bone crest (crestal group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) diagnosis of severe chronic periodontitis (corresponding to grade III or IV according to the actual classification); 2) good general health; 3) full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 20%; 4) at least two contralateral sextants with residual PDs of > 5 mm and persisting bleeding on probing (BoP) at posterior natural teeth 3 months after the completion of cause-related therapy
Key exclusion criteria (1 listed)
- 1) pregnancy and lactation; 2) smoking > 10 cigarettes/day; 3) intake of antibiotics in the previous 6 months. In addition, teeth with degree II or III mobility, horizontal bone loss higher than 1/3 of the root length or designed as abutment for prosthetic rehabilitation were also excluded from the study.
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 |
|---|---|---|
| FibReORS with apically positioned flap (apical position)Periodontal surgery including flap elevation. root surface scaling, bone remodeling and suture of the flap at 2 mm subcrestal position | Procedure or surgery | apical group |
| FibReORS with apically positioned flap (crestal position)Periodontal surgery including flap elevation. root surface scaling, bone remodeling and suture of the flap at either a crestal position | Procedure or surgery | Crestal group |
Primary outcome
Amount of soft tissue re-growth after FibReORS
Time frame: 6 months
The amount of regrowth is calculated from the position of the tissue at the end of the surgery
1 secondary outcome
Amount of KT increase after FibReORS
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Derived from this study: PubMed 37430291Piccoli GM, Romano F, Giraudi M, La Bruna N, Citterio F, Mariani GM, Baima G, Aimetti M. Effect of post-surgical flap position on soft tissue regrowth and keratinized tissue increase following fibre retention osseous resective surgery: a 6-month randomized study with multilevel analysis. BMC Oral Health. 2023 Jul 10;23(1):472. doi: 10.1186/s12903-023-03144-2.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibReORS with apically positioned flap (apical position) and FibReORS with apically positioned flap (crestal position) in people with Periodontitis and Periodontal Diseases, run by University of Turin, Italy 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of soft tissue re-growth after FibReORS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05140681, which also lists 1 linked publication.
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 1 Dec 2021.