Gingival RecessionNCT04028037
Effectiveness of Full-thickness Palatal Graft Technique (FTPGT) in Obtaining Complete Root Coverage
A study testing FTPGT treated patients and CAF+SCTG treated patients in people with Gingival Recession, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
In this randomized controlled clinical trial we will compare the clinical outcome of Full thickness palatal graft technique (FTPGT) to coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) in the treatment of RT1 (Cairo et al. classification) recessions. 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?
- FTPGT treated patients and CAF+SCTG treated patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2015to Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- systemic factors (no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation
- never smokers/former smokers >=10years
- a full-mouth plaque score (FMPS)and a full-mouth bleeding score (FMBS) lower than 15%
- no periodontal surgery on the experimental sites
- >= 20 teeth without mobility
- no presence of cervical carious lesions or periapical lesions at experimental sites
- at leat one RT1 buccal gingival recession
Who cannot join
- systemic diseases
- coagulation disorders
- medications affecting periodontal status in the previous 6 months
- pregnancy or lactation
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparison of Full-thickness Palatal Graft Technique (FTPGT) vs Coronally Advanced Flap With Subepithelial Connective Tissue Graft (CAF+SCTG)in Obtaining Complete Root Coverage: a Randomised Controlled Study
In this randomized controlled clinical trial we will compare the clinical outcome of Full thickness palatal graft technique (FTPGT) to coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) in the treatment of RT1 (Cairo et al. classification) recessions.
Forty patients, presenting at least one RT1 recession, will be treated with bilaminar procedures . 20 participants will receive FTPGT approach (test group) and 20 patients will undergo CAF+SCTG (control group). Complete root coverage (CRC) will be assumed as the main outcome at 12 months after treatment. Gingival recession (GR), clinical attachment level (CAL), pocket depth (PD), keratinized tissue width (KT,) thickness of keratinized tissue (GT) will be assessed at baseline and 12 months after treatment. Patient-reported outcome measures (PROMs) will be reported: namely, the number of painkiller tablets taken during the first week, the degree of general discomfort (D) experienced assessed on a VAS scale (0-10), the extent of changes in their eating habits (CFH), dentin hypersensitivity (DH), patient-reported aesthetic satisfaction (PRES) quantified on a VAS scale (0-10) and overall treatment satisfaction (OTS).
Read the detailed description
This study will be a prospective, randomized and controlled clinical trial designed to compare two modalities of treatment of RT1 recessions: FTPG versus CAF+SCTG. From each patient study one RT1 recession will be included. Clinical parameters will be evaluated at baseline and 12 months after treatment.
40 patients seeking treatment at the Unit of Periodontology of the University of Chieti, Pescara, Italy, and affected by RT1 recessions will be selected for the study.
All 40 patient will undergo a professional supra-gingival scaling by ultrasonic instruments. To each patient motivational oral home care instructions in order to acquire correct and pressure-less brushing technique and a-traumatic use of dental floss and/or inter-dental brush will be given. In addition electric toothbrush use with controlled pressure with extra-soft head will be suggested and instructions about it will be conferred. Only the achievement of supra-gingival plaque control through a-traumatic oral hygiene procedures will permit the access of the surgical step.
Custom made computer-generated table provides the randomly allocation of experimental unit in the two groups.
The post-surgical care will be founded for all patients on 2 g/day amoxicillin plus clavulanic acid for 6 days, oral ketoprofen for pain-control if needed . Two weeks after surgery suture will be removed. Plaque control of grafted area will be performed for 3 weeks after surgery through a double rinse in a day with 0.12% chlorhexidine digluconate solution. Furthermore, the patients will use a 1% chlorhexidine gel twice daily. Patients underwent weekly supragingival hygiene and motivational reinforcement for 6 weeks. Cautious brushing by a soft toothbrush and interdental brushing will be recommended only 2 weeks after sutures removal.
All measurements will be performed by a single experienced operator. Complete root coverage (CRC) will be assumed as the main outcome at 12 months after treatment. Gingival recession (GR), clinical attachment level (CAL), pocket depth (PD), keratinized tissue width (KT,) thickness of keratinized tissue (GT) will be assessed at baseline and 12 months after treatment.
PROMs will also be evaluated. That is, patients will be asked to write down the number of painkiller tablets (400 mg of ibuprofen) taken during the study the first week.
The degree of general discomfort (D) experienced will be assessed on a VAS scale (0-10), and the extent of changes in their eating habits (CFH) caused by the palate will be indicated wound. Dentin hypersensitivity (DH) will be evaluated at T0 and T1 according to a scale from 0 to 3 (0" reaction to the air stimulus; "1" reaction without requiring its termination; "2" reaction and request to stop it; "3" painful stimulus complaint).
Patient-reported aesthetic satisfaction (PRES) at T1 will also be quantified on a VAS scale (0-10). Overall treatment satisfaction (OTS) at T1 will be assessed by asking each patient if they would undergo surgery again (yes/no).
- Conditions
- Gingival Recession
- Being tested
- FTPGT treated patients, CAF+SCTG treated patients
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTPGT treated patientsProcedure or surgery
The recipient bed will be prepared according to Langer\&Langer modified technique. Intrasulcular incision will be performed from at least one tooth mesial and one tooth distal to the tooth with gingival recession, without vertical incisions.A split-thickness flap will be raised.The harvest of palatal graft will be done using FTPG technique. An incision, parallel to the gingival margin, deep to the bone, will be made. At the center of this incision, a "U" shaped one about 1-2mm deep will made, with the convex side towards the palatine vault.The width of the "U" incision will be equal to the width of the GR and the length will be 1mm greater.A split-thickness dissection of the area surrounding the "U" shaped incision will be done.The graft will be removed by detaching it from the bony surface.The graft will be made up of an apico-lateral portion of connective tissue and periosteum, and of a full-thickness central part.The palatal graft will be adapted to the recipient site and sutured.
CAF+SCTG treated patientsProcedure or surgery
According to De Sanctis \& Zucchelli, a tension-free trapezoidal flap will be elevated by the split-full-split technique and the anatomic papillae will be de-epithelialized. A 1-mm thick SCTG will be harvested from the palate as epithelialized graft. The height of the graft was equal to the distance between the buccal bone crest and the CEJ. After epithelium removal, the graft was positioned and sutured 1mm apical to the cement-enamel junction with 5-0 resorbable sutures . The SCTG will then be covered by the tension-free coronally positioned flap, sutured about 2mm over the CEJ by 5-0 silk sutures.
| Study group | Role | What they receive |
|---|---|---|
| FTPGT treated patients | Experimental | The recipient site will be prepared according to Langer\&Langer modified technique, raising a split-thickness flap without vertical incisions. The harvest of palatal graft will be done using FTPG technique ant it will be made up of an apico-lateral portion of connective tissue and periosteum, and of a full-thickness central "U" shaped part.The palatal graft will be adapted to the recipient site and sutured. Receives: Procedure: FTPGT treated patients |
| CAF+SCTG treated patients | Active comparator | A tension-free trapezoidal flap will be elevated by the split-full-split technique. A 1-mm thick SCTG will be harvested from the palate as epithelialized graft. After epithelium removal, the graft was positioned and sutured 1mm apical to the cement-enamel junction with 5-0 resorbable sutures . The SCTG will then be covered by the tension-free coronally positioned flap by 5-0 silk sutures. Receives: Procedure: CAF+SCTG treated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of Complete Root Coverage (CRC)
Percentage of teeth with CRC determined with the following formula: T0 GR-T1 GR/T0 GR.
Measured: 12 months
Secondary outcomes (10)
Clinical Attachment Level (CAL)
Distance between cementoenamel junction(CEJ) and depth of the pocket
Measured: 12 months
Pocket Depth (PD)
Distance between gingival margin and depth of the pocket
Measured: 12 months
Gingival Thickness (GT)
Gingival thickness (GT) was measured 1 mm apical to the sulcus depth, perpendicular to the gingiva until bone, using an endodontic K-file. GT was the distance from the tip of the K-file to the silicon disk.
Measured: 12 months
Keratinized Tissue width (KT)
Distance between gingival margin and mucogingival junction
Measured: 12 months
Number of painkiller tables
Number of painkiller tablets taken during the first week.
Measured: First week after surgery
Overall Discomfort (D)
Overall discomfort experienced, reported on a VAS scale (0-10)
Measured: 2 weeks after surgery
Feeding Habits Changes (CFH)
Extent of the feeding habits changes (CFH) caused by the palatal wound.
Measured: 2 weeks after surgery
Dentine hypersensitivity (DH)
Dentine hypersensitivity evaluated using Schiff cold air sensitivity scale
Measured: 12 months
Patient-Reported Esthetic Satisfaction (PRES)
Patient-reported esthetic satisfaction (PRES) quantified on a VAS scale (0-10), will be recorded after observing simultaneously 2 standardized photographs showing the treated site +2 mesial and 2 distal teeth and the MGJ.
Measured: 12 months
Overall Treatment Satisfaction (OTS)
Overall Treatment Satisfaction (OTS) will be assessed by asking each patient if he would undergo surgery again (yes/no).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study startNov 2015
- Primary completionOct 2018
- Study completionOct 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 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Paolantonio, G. d'Annunzio University
- Investigators
- michele paolantonio, Principal investigator, università G. D'annunzio Chieti-Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028037
- Sponsor's protocol ID
- uchieti2
- Status last verified
- Nov 2023
- First submitted
- 17 Jul 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paolantonio M, De Ninis P, Santamaria P, Balice G, Serroni M, Sinjari B, Frisone A, Di Gregorio S, Romano L, Murmura G, Femminella B. Clinical comparison of two surgical techniques in obtaining complete root coverage of single RT1 gingival recessions. Clin Oral Investig. 2025 Sep 10;29(10):444. doi: 10.1007/s00784-025-06491-2.
PubMed 40928531
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Full-thickness Palatal Graft Technique (FTPGT) vs Coronally Advanced Flap With Subepithelial Connective Tissue Graft (CAF+SCTG)in Obtaining Complete Root Coverage: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT04028037
- Acronym / sponsor ID
- uchieti2
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 22 Jul 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.
In this randomized controlled clinical trial we will compare the clinical outcome of Full thickness palatal graft technique (FTPGT) to coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) in the treatment of RT1 (Cairo et al. classification) recessions.
Forty patients, presenting at least one RT1 recession, will be treated with bilaminar procedures . 20 participants will receive FTPGT approach (test group) and 20 patients will undergo CAF+SCTG (control group). Complete root coverage (CRC) will be assumed as the main outcome at 12 months after treatment. Gingival recession (GR), clinical attachment level (CAL), pocket depth (PD), keratinized tissue width (KT,) thickness of keratinized tissue (GT) will be assessed at baseline and 12 months after treatment. Patient-reported outcome measures (PROMs) will be reported: namely, the number of painkiller tablets taken during the first week, the degree of general discomfort (D) experienced assessed on a VAS scale (0-10), the extent of changes in their eating habits (CFH), dentin hypersensitivity (DH), patient-reported aesthetic satisfaction (PRES) quantified on a VAS scale (0-10) and overall treatment satisfaction (OTS).
Detailed description
This study will be a prospective, randomized and controlled clinical trial designed to compare two modalities of treatment of RT1 recessions: FTPG versus CAF+SCTG. From each patient study one RT1 recession will be included. Clinical parameters will be evaluated at baseline and 12 months after treatment.
40 patients seeking treatment at the Unit of Periodontology of the University of Chieti, Pescara, Italy, and affected by RT1 recessions will be selected for the study.
All 40 patient will undergo a professional supra-gingival scaling by ultrasonic instruments. To each patient motivational oral home care instructions in order to acquire correct and pressure-less brushing technique and a-traumatic use of dental floss and/or inter-dental brush will be given. In addition electric toothbrush use with controlled pressure with extra-soft head will be suggested and instructions about it will be conferred. Only the achievement of supra-gingival plaque control through a-traumatic oral hygiene procedures will permit the access of the surgical step.
Custom made computer-generated table provides the randomly allocation of experimental unit in the two groups.
The post-surgical care will be founded for all patients on 2 g/day amoxicillin plus clavulanic acid for 6 days, oral ketoprofen for pain-control if needed . Two weeks after surgery suture will be removed. Plaque control of grafted area will be performed for 3 weeks after surgery through a double rinse in a day with 0.12% chlorhexidine digluconate solution. Furthermore, the patients will use a 1% chlorhexidine gel twice daily. Patients underwent weekly supragingival hygiene and motivational reinforcement for 6 weeks. Cautious brushing by a soft toothbrush and interdental brushing will be recommended only 2 weeks after sutures removal.
All measurements will be performed by a single experienced operator. Complete root coverage (CRC) will be assumed as the main outcome at 12 months after treatment. Gingival recession (GR), clinical attachment level (CAL), pocket depth (PD), keratinized tissue width (KT,) thickness of keratinized tissue (GT) will be assessed at baseline and 12 months after treatment.
PROMs will also be evaluated. That is, patients will be asked to write down the number of painkiller tablets (400 mg of ibuprofen) taken during the study the first week.
The degree of general discomfort (D) experienced will be assessed on a VAS scale (0-10), and the extent of changes in their eating habits (CFH) caused by the palate will be indicated wound. Dentin hypersensitivity (DH) will be evaluated at T0 and T1 according to a scale from 0 to 3 (0" reaction to the air stimulus; "1" reaction without requiring its termination; "2" reaction and request to stop it; "3" painful stimulus complaint).
Patient-reported aesthetic satisfaction (PRES) at T1 will also be quantified on a VAS scale (0-10). Overall treatment satisfaction (OTS) at T1 will be assessed by asking each patient if they would undergo surgery again (yes/no).
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 |
|---|---|---|
| FTPGT treated patients | Experimental | Procedure: FTPGT treated patientsThe recipient site will be prepared according to Langer\&Langer modified technique, raising a split-thickness flap without vertical incisions. The harvest of palatal graft will be done using FTPG technique ant it will be made up of an apico-lateral portion of connective tissue and periosteum, and of a full-thickness central "U" shaped part.The palatal graft will be adapted to the recipient site and sutured. |
| CAF+SCTG treated patients | Active comparator | Procedure: CAF+SCTG treated patientsA tension-free trapezoidal flap will be elevated by the split-full-split technique. A 1-mm thick SCTG will be harvested from the palate as epithelialized graft. After epithelium removal, the graft was positioned and sutured 1mm apical to the cement-enamel junction with 5-0 resorbable sutures . The SCTG will then be covered by the tension-free coronally positioned flap by 5-0 silk sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- systemic factors (no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation
- never smokers/former smokers >=10years
- a full-mouth plaque score (FMPS)and a full-mouth bleeding score (FMBS) lower than 15%
- no periodontal surgery on the experimental sites
- >= 20 teeth without mobility
Key exclusion criteria (5 listed)
- systemic diseases
- coagulation disorders
- medications affecting periodontal status in the previous 6 months
- pregnancy or lactation
- Smokers
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 |
|---|---|---|
| FTPGT treated patientsThe recipient bed will be prepared according to Langer\&Langer modified technique. Intrasulcular incision will be performed from at least one tooth mesial and one tooth distal to the tooth with gingival recession, without vertical incisions.A split-thickness flap will be raised.The harvest of palatal graft will be done using FTPG technique. An incision, parallel to the gingival margin, deep to the bone, will be made. At the center of this incision, a "U" shaped one about 1-2mm deep will made, with the convex side towards the palatine vault.The width of the "U" incision will be equal to the width of the GR and the length will be 1mm greater.A split-thickness dissection of the area surrounding the "U" shaped incision will be done.The graft will be removed by detaching it from the bony surface.The graft will be made up of an apico-lateral portion of connective tissue and periosteum, and of a full-thickness central part.The palatal graft will be adapted to the recipient site and sutured. | Procedure or surgery | FTPGT treated patients |
| CAF+SCTG treated patientsAccording to De Sanctis \& Zucchelli, a tension-free trapezoidal flap will be elevated by the split-full-split technique and the anatomic papillae will be de-epithelialized. A 1-mm thick SCTG will be harvested from the palate as epithelialized graft. The height of the graft was equal to the distance between the buccal bone crest and the CEJ. After epithelium removal, the graft was positioned and sutured 1mm apical to the cement-enamel junction with 5-0 resorbable sutures . The SCTG will then be covered by the tension-free coronally positioned flap, sutured about 2mm over the CEJ by 5-0 silk sutures. | Procedure or surgery | CAF+SCTG treated patients |
Primary outcome
Percentage (%) of Complete Root Coverage (CRC)
Time frame: 12 months
Percentage of teeth with CRC determined with the following formula: T0 GR-T1 GR/T0 GR.
10 secondary outcomes
Clinical Attachment Level (CAL)
Time frame: 12 months
Pocket Depth (PD)
Time frame: 12 months
Gingival Thickness (GT)
Time frame: 12 months
Keratinized Tissue width (KT)
Time frame: 12 months
Number of painkiller tables
Time frame: First week after surgery
Overall Discomfort (D)
Time frame: 2 weeks after surgery
Feeding Habits Changes (CFH)
Time frame: 2 weeks after surgery
Dentine hypersensitivity (DH)
Time frame: 12 months
Patient-Reported Esthetic Satisfaction (PRES)
Time frame: 12 months
Overall Treatment Satisfaction (OTS)
Time frame: 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 7 Nov 2023.
- Derived from this study: PubMed 40928531Paolantonio M, De Ninis P, Santamaria P, Balice G, Serroni M, Sinjari B, Frisone A, Di Gregorio S, Romano L, Murmura G, Femminella B. Clinical comparison of two surgical techniques in obtaining complete root coverage of single RT1 gingival recessions. Clin Oral Investig. 2025 Sep 10;29(10):444. doi: 10.1007/s00784-025-06491-2.
- 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.
michele paolantonio principal investigator
università G. D'annunzio Chieti-Pescara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FTPGT treated patients and CAF+SCTG treated patients in people with Gingival Recession, run by G. d'Annunzio University 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 7 inclusion and 5 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 7 Nov 2023. 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?
Percentage (%) of Complete Root Coverage (CRC) (time frame: 12 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 NCT04028037, 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 7 Nov 2023.