Gingival RecessionNCT05472233
Effect of Suturing Protocols on Coronally Advanced Flap for Root Coverage Outcomes
A study testing Suture removal after Coronally Positioned Flap in people with Gingival Recession, run by University of Cagliari at 1 site in Italy.
Trial summary
The purpose of this retrospective study is to investigate whether suturing protocols (suture removal timing) influence root coverage outcomes in recession defects treated with a coronally advanced flap (CAF) procedure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Suture removal after Coronally Positioned Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 31 Mar 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
- Patients not affected by active periodontitis
- Single recessions on non-restored non-molar teeth
- CAF protocols using vertical releasing incisions
- records of patients clearly reporting timing of suture removals and root coverage outcomes at 6 months
Who cannot join
- Adjacent recessions
- Recessions on molar teeth
- Coronally advanced flaps without releasing incisions
- Patients with active periodontitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sutures Removal Protocols on Coronally Advanced Flap for Root Coverage Outcomes: a Retrospective Study
The purpose of this retrospective study is to investigate whether suturing protocols (suture removal timing) influence root coverage outcomes in recession defects treated with a coronally advanced flap (CAF) procedure.
Read the detailed description
The aim of this study is to assess whether the timing of suture removal may influence the number of sites exhibiting complete coverage (CRC) or the mean root coverage (MRC) obtained in single-tooth recession-type defects treated by coronally advanced flap (CAF).
Records from patients that underwent a coronally advanced flap (CAF) procedure for root coverage will be analyzed. This surgical procedure is aimed at the treatment of root recessions that may arise following periodontal disease or mechanical trauma. The procedure, after obtaining deep local anesthesia, involves a sulcular incision on the buccal side and extending the incision mesially and distally to the base of the adjacent papillae. Two vertical incisions are then made at the corner of the adjacent tooth line and extended into the alveolar mucosa. A mixed thickness flap is then elevated and coronally advanced by releasing incisions through the periosteum to allow for flap placement to cover the recession without tension. The papillae are de-epithelized to provide the bed of connective tissue for the adaptation of the flap which is then sutured with single stitches.
The records, complete with photographic documentation, of all patients who have undergone this procedure will be identified and will be divided into two groups: those in which the sutures were removed at 2 weeks and those in which the sutures were removed at 3 or more weeks.
CRC as present or absent (yes/no) and MRC (percentage of roof surface that has been successfully covered) six months after surgery will be assessed in these patients.
The presence of patient discomfort on the day of suture removal will be recorded as present / absent to assess whether the permanence of the sutures for longer or shorter influences the patient's perception of the surgery.
The results will be compared between the two groups.
- Conditions
- Gingival Recession
- Being tested
- Suture removal after Coronally Positioned Flap
- Keywords
- Gingival recession, Sutures, Root coverage, Healing
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture removal after Coronally Positioned FlapProcedure or surgery
Sutures are removed after different healing period post coronally positioned flap surgery, this latter is a procedure that aims at surgically advancing the gingiva in order to cover dehiscences of the soft tissues uncovering dental roots.
| Study group | Role | What they receive |
|---|---|---|
| 2weeks | Active comparator | Suture removal at 2 weeks post intervention Receives: Procedure: Suture removal after Coronally Positioned Flap |
| 3+weeks | Experimental | Suture removal at 3 weeks minimum post intervention Receives: Procedure: Suture removal after Coronally Positioned Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Root Coverage
Achievement of 100% root coverage, measured as yes / no
Measured: 6 months
Mean Root Coverage
Percentage of the root recession that has been successfully covered after the surgical procedure
Measured: 6 months
Secondary outcomes (1)
Patient discomfort
Discomfort reported by the patient (present/absent)
Measured: at suture removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Sep 2022
- Primary completion30 Nov 2022
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Retrospective cohort study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Alberto Valente, DDS, MS, PhD, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472233
- Sponsor's protocol ID
- Perio1
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2022
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared in a publication after the end of the study
Publications
Tatakis DN, Chambrone L. The Effect of Suturing Protocols on Coronally Advanced Flap Root-Coverage Outcomes: A Meta-Analysis. J Periodontol. 2016 Feb;87(2):148-55. doi: 10.1902/jop.2015.150394. Epub 2015 Oct 8.
PubMed 26447751Tavelli L, Barootchi S, Ravida A, Suarez-Lopez Del Amo F, Rasperini G, Wang HL. Influence of suturing technique on marginal flap stability following coronally advanced flap: a cadaver study. Clin Oral Investig. 2019 Apr;23(4):1641-1651. doi: 10.1007/s00784-018-2597-5. Epub 2018 Aug 27.
PubMed 30151706Huang LH, Wang HL. Sling and tag suturing technique for coronally advanced flap. Int J Periodontics Restorative Dent. 2007 Aug;27(4):379-85.
PubMed 17726994Huang LH, Neiva RE, Wang HL. Factors affecting the outcomes of coronally advanced flap root coverage procedure. J Periodontol. 2005 Oct;76(10):1729-34. doi: 10.1902/jop.2005.76.10.1729.
PubMed 16253095Tatakis DN, Chambrone L, Allen EP, Langer B, McGuire MK, Richardson CR, Zabalegui I, Zadeh HH. Periodontal soft tissue root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S52-5. doi: 10.1902/jop.2015.140376. Epub 2014 Oct 15.
PubMed 25315018Chambrone L, Pannuti CM, Tu YK, Chambrone LA. Evidence-based periodontal plastic surgery. II. An individual data meta-analysis for evaluating factors in achieving complete root coverage. J Periodontol. 2012 Apr;83(4):477-90. doi: 10.1902/jop.2011.110382. Epub 2011 Aug 22.
PubMed 21859324
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sutures Removal Protocols on Coronally Advanced Flap for Root Coverage Outcomes: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05472233
- Acronym / sponsor ID
- Perio1
- Conditions
- Gingival Recession
- Keywords
- Gingival recession, Sutures, Root coverage, Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 25 Jul 2022 (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 purpose of this retrospective study is to investigate whether suturing protocols (suture removal timing) influence root coverage outcomes in recession defects treated with a coronally advanced flap (CAF) procedure.
Detailed description
The aim of this study is to assess whether the timing of suture removal may influence the number of sites exhibiting complete coverage (CRC) or the mean root coverage (MRC) obtained in single-tooth recession-type defects treated by coronally advanced flap (CAF).
Records from patients that underwent a coronally advanced flap (CAF) procedure for root coverage will be analyzed. This surgical procedure is aimed at the treatment of root recessions that may arise following periodontal disease or mechanical trauma. The procedure, after obtaining deep local anesthesia, involves a sulcular incision on the buccal side and extending the incision mesially and distally to the base of the adjacent papillae. Two vertical incisions are then made at the corner of the adjacent tooth line and extended into the alveolar mucosa. A mixed thickness flap is then elevated and coronally advanced by releasing incisions through the periosteum to allow for flap placement to cover the recession without tension. The papillae are de-epithelized to provide the bed of connective tissue for the adaptation of the flap which is then sutured with single stitches.
The records, complete with photographic documentation, of all patients who have undergone this procedure will be identified and will be divided into two groups: those in which the sutures were removed at 2 weeks and those in which the sutures were removed at 3 or more weeks.
CRC as present or absent (yes/no) and MRC (percentage of roof surface that has been successfully covered) six months after surgery will be assessed in these patients.
The presence of patient discomfort on the day of suture removal will be recorded as present / absent to assess whether the permanence of the sutures for longer or shorter influences the patient's perception of the surgery.
The results will be compared between the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Retrospective cohort study
| Arm | Type | Receives |
|---|---|---|
| 2weeks | Active comparator | Procedure: Suture removal after Coronally Positioned FlapSuture removal at 2 weeks post intervention |
| 3+weeks | Experimental | Procedure: Suture removal after Coronally Positioned FlapSuture removal at 3 weeks minimum post intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients not affected by active periodontitis
- Single recessions on non-restored non-molar teeth
- CAF protocols using vertical releasing incisions
- records of patients clearly reporting timing of suture removals and root coverage outcomes at 6 months
Key exclusion criteria (4 listed)
- Adjacent recessions
- Recessions on molar teeth
- Coronally advanced flaps without releasing incisions
- Patients with active periodontitis
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 |
|---|---|---|
| Suture removal after Coronally Positioned FlapSutures are removed after different healing period post coronally positioned flap surgery, this latter is a procedure that aims at surgically advancing the gingiva in order to cover dehiscences of the soft tissues uncovering dental roots. | Procedure or surgery | 2weeks, 3+weeks |
Primary outcome
Complete Root Coverage
Time frame: 6 months
Achievement of 100% root coverage, measured as yes / no
Mean Root Coverage
Time frame: 6 months
Percentage of the root recession that has been successfully covered after the surgical procedure
1 secondary outcome
Patient discomfort
Time frame: at suture removal
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 24 Jul 2025.
- Background: PubMed 26447751Tatakis DN, Chambrone L. The Effect of Suturing Protocols on Coronally Advanced Flap Root-Coverage Outcomes: A Meta-Analysis. J Periodontol. 2016 Feb;87(2):148-55. doi: 10.1902/jop.2015.150394. Epub 2015 Oct 8.
- Background: PubMed 30151706Tavelli L, Barootchi S, Ravida A, Suarez-Lopez Del Amo F, Rasperini G, Wang HL. Influence of suturing technique on marginal flap stability following coronally advanced flap: a cadaver study. Clin Oral Investig. 2019 Apr;23(4):1641-1651. doi: 10.1007/s00784-018-2597-5. Epub 2018 Aug 27.
- Background: PubMed 17726994Huang LH, Wang HL. Sling and tag suturing technique for coronally advanced flap. Int J Periodontics Restorative Dent. 2007 Aug;27(4):379-85.
- Background: PubMed 16253095Huang LH, Neiva RE, Wang HL. Factors affecting the outcomes of coronally advanced flap root coverage procedure. J Periodontol. 2005 Oct;76(10):1729-34. doi: 10.1902/jop.2005.76.10.1729.
- Background: PubMed 25315018Tatakis DN, Chambrone L, Allen EP, Langer B, McGuire MK, Richardson CR, Zabalegui I, Zadeh HH. Periodontal soft tissue root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S52-5. doi: 10.1902/jop.2015.140376. Epub 2014 Oct 15.
- Background: PubMed 21859324Chambrone L, Pannuti CM, Tu YK, Chambrone LA. Evidence-based periodontal plastic surgery. II. An individual data meta-analysis for evaluating factors in achieving complete root coverage. J Periodontol. 2012 Apr;83(4):477-90. doi: 10.1902/jop.2011.110382. Epub 2011 Aug 22.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared in a publication after the end of the study
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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 Suture removal after Coronally Positioned Flap in people with Gingival Recession, run by University of Cagliari 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 4 inclusion and 4 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 24 Jul 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?
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?
Complete Root Coverage (time frame: 6 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?
On the ClinicalTrials.gov record for NCT05472233, which also lists 6 linked publications.
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 24 Jul 2025.