Gingival RecessionNCT03862534
CAF With or Without CTG for the Treatment of Single Maxillary Gingival Recession With NCCL
A study testing CAF and CAF + CTG in people with Gingival Recession, run by University of Florence.
Trial summary
This studies evaluate the efficacy of the coronally advanced flap (CAF) with or without connective tissue graft (CTG) for the treatment of single maxillary recession associated to non carious cervical lesion (NCCL). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- CAF and CAF + CTG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- No systemic diseases or pregnancy.
- Self-reported smoking ≤ 10 cigarettes/day.
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 10% (measured at four sites per tooth).
- Presence of single RT1 buccal gingival recessions ≥ 2 mm of depth located in the anterior area of the upper jaw (central and lateral incisors, canine, first and second pre-molars, first molar) and associated with aesthetic complains and or dental sensitivity.
- Presence of NCCL associated with recession
- No history of mucogingival or periodontal surgery at experimental sites.
Who cannot join
- Prosthetic crown at experimental teeth.
- Gingival recessions presenting minimal amount (< 1mm) of apico-coronal keratinized tissue (KT) extension apical to recession area.
About this study
Official title: Coronally Advanced Flap (CAF) and Composite Restoration of the Enamel With or Without Connective Tissue Graft (CTG) for the Treatment of Single Maxillary Gingival Recession With Non-carious Cervical Lesion (NCCL). A Randomized Controlled Clinical Trial
This studies evaluate the efficacy of the coronally advanced flap (CAF) with or without connective tissue graft (CTG) for the treatment of single maxillary recession associated to non carious cervical lesion (NCCL).
- Conditions
- Gingival Recession
- Being tested
- CAF, CAF + CTG
- Keywords
- Gingival recession, Non-carious cervical lesion, Connective tissue graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAFProcedure or surgery
After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised, coronally advanced and sutured to cover the recession
CAF + CTGProcedure or surgery
After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised. Then a connective tissue graft was harvested from the palate and sutured over the exposed root. Finally the flap was coronally advanced and sutured to cover the recession
| Study group | Role | What they receive |
|---|---|---|
| CAF | Experimental | After the restoration of the enamel patients were treated with a CAF Receives: Procedure: CAF |
| CAF + CTG | Experimental | After the restoration of the enamel patients were treated with a CAF + CTG Receives: Procedure: CAF + CTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession Reduction
Difference between gingival recession at 12 months and baseline, measured with a periodontal probe.
Measured: At 12 months
Complete Root Coverage (CRC)
Absence or presence of gingival recession at 12 months follow-up.
Measured: At 12 months
Secondary outcomes (11)
Root coverage Esthetic Score (RES)
Overall esthetic score from 0 to 10 evaluated by the blinded examiner. Higher values represent a better outcome. (Pini-Prato et al. 2011)
Measured: At 12 months
Gingival Thickness (GT)
Gingival thickness in mm, measured with an endodontic file and a digital caliper.
Measured: Baseline - 12 months
Keratinized Tissue (KT)
Width of the keratinized gingiva measured in mm from the gingival margin to the muco-gingival-junction using a periodontal probe
Measured: Baseline - 6 and 12 months
KTgain
Gain of Keratinized Tissue measured as the difference between KT at 12 months and KT baseline
Measured: At 12 months
Gingival Recesión (REC)
The distance between the reconstructed cementum enamel junction and the gingival margin measured in mm with a periodontal probe
Measured: Baseline - 6 and 12 months
Root sensitivity
Toot sensitivity reported by the patient present or absent
Measured: Baseline - 6 and 12 months
SensVAS
Toot sensitivity reported by the patient on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.
Measured: Baseline - 6 and 12 months
SurTime
Surgical Time in minutes from the end of anesthesia to the sutures
Measured: At surgery
Anti-infammTab
Number of tablets of anti-inflammatory drug taken in the first week post-operatively by the patients.
Measured: 1 week post-surgery
DiscVAS
Post Operative Discomfort reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.
Measured: 1 week post-surgery
AesthVAS
Aesthetic overall satisfaction reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent better outcomes.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study startOct 2014
- Primary completionSep 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Principal investigator, Dr. Francesco Cairo, University of Florence
- Investigators
- Francesco Cairo, DDS, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862534
- Sponsor's protocol ID
- RCT restored CEJ
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2019
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cairo F. Periodontal plastic surgery of gingival recessions at single and multiple teeth. Periodontol 2000. 2017 Oct;75(1):296-316. doi: 10.1111/prd.12186.
PubMed 28758301Cairo F, Pagliaro U, Buti J, Baccini M, Graziani F, Tonelli P, Pagavino G, Tonetti MS. Root coverage procedures improve patient aesthetics. A systematic review and Bayesian network meta-analysis. J Clin Periodontol. 2016 Nov;43(11):965-975. doi: 10.1111/jcpe.12603. Epub 2016 Sep 16.
PubMed 27454460Cairo F, Pini-Prato GP. A technique to identify and reconstruct the cementoenamel junction level using combined periodontal and restorative treatment of gingival recession. A prospective clinical study. Int J Periodontics Restorative Dent. 2010 Dec;30(6):573-81.
PubMed 20967303Hwang D, Wang HL. Flap thickness as a predictor of root coverage: a systematic review. J Periodontol. 2006 Oct;77(10):1625-34. doi: 10.1902/jop.2006.060107.
PubMed 17032103Cortellini P, Tonetti M, Baldi C, Francetti L, Rasperini G, Rotundo R, Nieri M, Franceschi D, Labriola A, Prato GP. Does placement of a connective tissue graft improve the outcomes of coronally advanced flap for coverage of single gingival recessions in upper anterior teeth? A multi-centre, randomized, double-blind, clinical trial. J Clin Periodontol. 2009 Jan;36(1):68-79. doi: 10.1111/j.1600-051X.2008.01346.x. Epub 2008 Nov 20.
PubMed 19046326Santamaria MP, da Silva Feitosa D, Nociti FH Jr, Casati MZ, Sallum AW, Sallum EA. Cervical restoration and the amount of soft tissue coverage achieved by coronally advanced flap: a 2-year follow-up randomized-controlled clinical trial. J Clin Periodontol. 2009 May;36(5):434-41. doi: 10.1111/j.1600-051X.2009.01389.x.
PubMed 19419445Zucchelli G, Gori G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Non-carious cervical lesions associated with gingival recessions: a decision-making process. J Periodontol. 2011 Dec;82(12):1713-24. doi: 10.1902/jop.2011.110080. Epub 2011 May 4.
PubMed 21542735
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronally Advanced Flap (CAF) and Composite Restoration of the Enamel With or Without Connective Tissue Graft (CTG) for the Treatment of Single Maxillary Gingival Recession With Non-carious Cervical Lesion (NCCL). A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03862534
- Acronym / sponsor ID
- RCT restored CEJ
- Conditions
- Gingival Recession
- Keywords
- Gingival recession, Non-carious cervical lesion, Connective tissue graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- Oct 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 5 Mar 2019 (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.
This studies evaluate the efficacy of the coronally advanced flap (CAF) with or without connective tissue graft (CTG) for the treatment of single maxillary recession associated to non carious cervical lesion (NCCL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF | Experimental | Procedure: CAFAfter the restoration of the enamel patients were treated with a CAF |
| CAF + CTG | Experimental | Procedure: CAF + CTGAfter the restoration of the enamel patients were treated with a CAF + CTG |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- No systemic diseases or pregnancy.
- Self-reported smoking ≤ 10 cigarettes/day.
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 10% (measured at four sites per tooth).
- Presence of single RT1 buccal gingival recessions ≥ 2 mm of depth located in the anterior area of the upper jaw (central and lateral incisors, canine, first and second pre-molars, first molar) and associated with aesthetic complains and or dental sensitivity.
Key exclusion criteria (2 listed)
- Prosthetic crown at experimental teeth.
- Gingival recessions presenting minimal amount (< 1mm) of apico-coronal keratinized tissue (KT) extension apical to recession area.
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 |
|---|---|---|
| CAFAfter the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised, coronally advanced and sutured to cover the recession | Procedure or surgery | CAF |
| CAF + CTGAfter the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised. Then a connective tissue graft was harvested from the palate and sutured over the exposed root. Finally the flap was coronally advanced and sutured to cover the recession | Procedure or surgery | CAF + CTG |
Primary outcome
Recession Reduction
Time frame: At 12 months
Difference between gingival recession at 12 months and baseline, measured with a periodontal probe.
Complete Root Coverage (CRC)
Time frame: At 12 months
Absence or presence of gingival recession at 12 months follow-up.
11 secondary outcomes
Root coverage Esthetic Score (RES)
Time frame: At 12 months
Gingival Thickness (GT)
Time frame: Baseline - 12 months
Keratinized Tissue (KT)
Time frame: Baseline - 6 and 12 months
KTgain
Time frame: At 12 months
Gingival Recesión (REC)
Time frame: Baseline - 6 and 12 months
Root sensitivity
Time frame: Baseline - 6 and 12 months
SensVAS
Time frame: Baseline - 6 and 12 months
SurTime
Time frame: At surgery
Anti-infammTab
Time frame: 1 week post-surgery
DiscVAS
Time frame: 1 week post-surgery
AesthVAS
Time frame: At 12 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 27 Mar 2025.
- Background: PubMed 28758301Cairo F. Periodontal plastic surgery of gingival recessions at single and multiple teeth. Periodontol 2000. 2017 Oct;75(1):296-316. doi: 10.1111/prd.12186.
- Background: PubMed 27454460Cairo F, Pagliaro U, Buti J, Baccini M, Graziani F, Tonelli P, Pagavino G, Tonetti MS. Root coverage procedures improve patient aesthetics. A systematic review and Bayesian network meta-analysis. J Clin Periodontol. 2016 Nov;43(11):965-975. doi: 10.1111/jcpe.12603. Epub 2016 Sep 16.
- Background: PubMed 20967303Cairo F, Pini-Prato GP. A technique to identify and reconstruct the cementoenamel junction level using combined periodontal and restorative treatment of gingival recession. A prospective clinical study. Int J Periodontics Restorative Dent. 2010 Dec;30(6):573-81.
- Background: PubMed 17032103Hwang D, Wang HL. Flap thickness as a predictor of root coverage: a systematic review. J Periodontol. 2006 Oct;77(10):1625-34. doi: 10.1902/jop.2006.060107.
- Background: PubMed 19046326Cortellini P, Tonetti M, Baldi C, Francetti L, Rasperini G, Rotundo R, Nieri M, Franceschi D, Labriola A, Prato GP. Does placement of a connective tissue graft improve the outcomes of coronally advanced flap for coverage of single gingival recessions in upper anterior teeth? A multi-centre, randomized, double-blind, clinical trial. J Clin Periodontol. 2009 Jan;36(1):68-79. doi: 10.1111/j.1600-051X.2008.01346.x. Epub 2008 Nov 20.
- Background: PubMed 19419445Santamaria MP, da Silva Feitosa D, Nociti FH Jr, Casati MZ, Sallum AW, Sallum EA. Cervical restoration and the amount of soft tissue coverage achieved by coronally advanced flap: a 2-year follow-up randomized-controlled clinical trial. J Clin Periodontol. 2009 May;36(5):434-41. doi: 10.1111/j.1600-051X.2009.01389.x.
- Background: PubMed 21542735Zucchelli G, Gori G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Non-carious cervical lesions associated with gingival recessions: a decision-making process. J Periodontol. 2011 Dec;82(12):1713-24. doi: 10.1902/jop.2011.110080. Epub 2011 May 4.
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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.
Francesco Cairo, DDS principal investigator
University of Florence
Questions about this trial
What is this clinical trial studying?
A study testing CAF and CAF + CTG in people with Gingival Recession, run by University of Florence.
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 7 inclusion and 2 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 27 Mar 2025. 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?
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?
Recession Reduction (time frame: At 12 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 NCT03862534, which also lists 7 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 27 Mar 2025.