Gingival RecessionNCT05460182
Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial
A study testing CAF+CTG and CAF in people with Gingival Recession, run by University of Florence at 1 site in Italy.
Trial summary
Background: The aim of this randomized clinical trial (RCT) was to evaluate the adjunctive benefit of Connective Tissue Graft (CTG) to Coronally Advanced Flap (CAF) for the treatment of gingival recession associated with inter-dental clinical attachment loss equal or smaller to the buccal attachment loss (RT2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession
- What is being tested?
- CAF+CTG and CAF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2021to 1 Mar 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoking < 20 cigarettes/day.
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 15% (measured at four sites per tooth).
- Presence of at least one RT2 (Cairo et al. 2011) buccal gingival recession > 2 mm of depth
- Only gingival recessions localized at upper central and lateral incisors, canine, and first and second pre-molars associated with aesthetic problems and/ordental hypersensitivity were considered.
- Presence of an identifiable CEJ
Who cannot join
- Systemic diseases or pregnancy.
- Systemic antibiotic therapy in the last 6 months.
- Active periodontal disease with sites showing probing depth >4 mm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coronally Advanced Flap With and Without Connective Tissue Graft for the Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial - 10 Years Results
Background: The aim of this randomized clinical trial (RCT) was to evaluate the adjunctive benefit of Connective Tissue Graft (CTG) to Coronally Advanced Flap (CAF) for the treatment of gingival recession associated with inter-dental clinical attachment loss equal or smaller to the buccal attachment loss (RT2). Material and Methods:The patients were randomly assigned to CAF+CTG (test group) or to CAF alone (Control group). Measurements were performed by a blind and calibrated examiner. Outcome measures included complete root coverage (CRC), recession reduction (RecRed), Root coverage Esthetic Score (RES), intra-operative and post-operative morbidity, and root sensitivity.
- Conditions
- Gingival Recession
- Being tested
- CAF+CTG, CAF
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAF+CTGOther
Coronally Advanced Flap + Connective Tissue Graft
CAFOther
Coronally Advanced Flap
| Study group | Role | What they receive |
|---|---|---|
| CAF+CTG | Experimental | After local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed.
A 1-2-mm-thick CTG was harvested using a single incision approach from the palate in the area between the second pre-molar and the second molar. The wound on the donor site of the palate was then sutured. The graft was positioned on the instrumented root surface immediately apical or at the level of the CEJ and then stabilized using a compressive crossing suture, anchored to the periosteum apical to the graft and closed with a palatal knot. The flap was coronally displaced 1-2 mm above the CEJ and sutured Receives: Other: CAF+CTG |
| CAF | Active comparator | After local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed. The flap was coronally displaced 1-2 mm above the CEJ and sutured Receives: Other: CAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Root Coverage (CRC)
Complete Root Coverage: absence of gingival recession (Yes/No)
Measured: After the intervention (10 years)
Secondary outcomes (2)
Recession Reduction (RecRed)
Change of the gingival recession, in mm
Measured: After the intervention (10 years)
Root Coverage Aesthetic Score (RES)
A scoring system ranging from 0 to 10
Measured: After the intervention (10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Aug 2021
- Primary completion1 Nov 2021
- Study completion1 Mar 2022
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Francesco Cairo, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460182
- Sponsor's protocol ID
- RT2-10
- Status last verified
- Dec 2024
- First submitted
- 6 Jul 2022
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cairo F, Cortellini P, Barbato L, Masseti L, Mervelt J, Nieri M, Pini Prato GP, Tonetti MS. Long-term comparison of root coverage procedures at single RT2 maxillary gingival recessions: Ten-year extension results from a randomized, controlled clinical trial. J Clin Periodontol. 2023 Apr;50(4):511-519. doi: 10.1111/jcpe.13778. Epub 2023 Jan 24.
PubMed 36644804
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronally Advanced Flap With and Without Connective Tissue Graft for the Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial - 10 Years Results
- ClinicalTrials.gov ID
- NCT05460182
- Acronym / sponsor ID
- RT2-10
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 15 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.
Background: The aim of this randomized clinical trial (RCT) was to evaluate the adjunctive benefit of Connective Tissue Graft (CTG) to Coronally Advanced Flap (CAF) for the treatment of gingival recession associated with inter-dental clinical attachment loss equal or smaller to the buccal attachment loss (RT2). Material and Methods:The patients were randomly assigned to CAF+CTG (test group) or to CAF alone (Control group). Measurements were performed by a blind and calibrated examiner. Outcome measures included complete root coverage (CRC), recession reduction (RecRed), Root coverage Esthetic Score (RES), intra-operative and post-operative morbidity, and root sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF+CTG | Experimental | Other: CAF+CTGAfter local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed. A 1-2-mm-thick CTG was harvested using a single incision approach from the palate in the area between the second pre-molar and the second molar. The wound on the donor site of the palate was then sutured. The graft was positioned on the instrumented root surface immediately apical or at the level of the CEJ and then stabilized using a compressive crossing suture, anchored to the periosteum apical to the graft and closed with a palatal knot. The flap was coronally displaced 1-2 mm above the CEJ and sutured |
| CAF | Active comparator | Other: CAFAfter local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed. The flap was coronally displaced 1-2 mm above the CEJ and sutured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Smoking < 20 cigarettes/day.
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 15% (measured at four sites per tooth).
- Presence of at least one RT2 (Cairo et al. 2011) buccal gingival recession > 2 mm of depth
- Only gingival recessions localized at upper central and lateral incisors, canine, and first and second pre-molars associated with aesthetic problems and/ordental hypersensitivity were considered.
- Presence of an identifiable CEJ
Key exclusion criteria (3 listed)
- Systemic diseases or pregnancy.
- Systemic antibiotic therapy in the last 6 months.
- Active periodontal disease with sites showing probing depth >4 mm.
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 |
|---|---|---|
| CAF+CTGCoronally Advanced Flap + Connective Tissue Graft | Other | CAF+CTG |
| CAFCoronally Advanced Flap | Other | CAF |
Primary outcome
Complete Root Coverage (CRC)
Time frame: After the intervention (10 years)
Complete Root Coverage: absence of gingival recession (Yes/No)
2 secondary outcomes
Recession Reduction (RecRed)
Time frame: After the intervention (10 years)
Root Coverage Aesthetic Score (RES)
Time frame: After the intervention (10 years)
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 4 Dec 2024.
- Derived from this study: PubMed 36644804Cairo F, Cortellini P, Barbato L, Masseti L, Mervelt J, Nieri M, Pini Prato GP, Tonetti MS. Long-term comparison of root coverage procedures at single RT2 maxillary gingival recessions: Ten-year extension results from a randomized, controlled clinical trial. J Clin Periodontol. 2023 Apr;50(4):511-519. doi: 10.1111/jcpe.13778. Epub 2023 Jan 24.
- Individual participant dataSharing planned: Undecided
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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 CAF+CTG and CAF in people with Gingival Recession, 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 5 inclusion and 3 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 4 Dec 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 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 (CRC) (time frame: After the intervention (10 years)). 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 NCT05460182, 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 4 Dec 2024.