Gingival RecessionNCT05783258
Connective Tissue Graft From Tuberosity Area and L-PRF Associated With Coronally Advanced Flap for Root Coverage
A study testing Periodontal surgery with CAF+tSCTG and Periodontal surgery with CAF+L-PRF in people with Gingival Recession, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
The aim of the present randomized controlled clinical study is to compare the efficacy of subepithelial connective tissue graft harvested from the maxillary retromolar tubeosity area and L-PRF membranes in the treatment of RT1 recessions by coronally advanced flap. 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?
- Periodontal surgery with CAF+tSCTG and Periodontal surgery with CAF+L-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jun 2022to 29 Oct 2023
- 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
- Presence of a class RT1 recession;
- age > 18 years;
- systemic health conditions that do not affect the periodontium;
- Non smoker;
- FMPS and FMBS values < 20% before the surgical procedure;
- absence of implants or subgingival restorations in the sites to be treated;
- presence of adequate tissue distal to the last maxillary molar.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of the Coronally Advanced Flap (CAF) Using a Connective Tissue Graft From the Tuberosity (tCTG) or L-PRF Membranes: a Randomized Controlled Clinical Trial.
The aim of the present randomized controlled clinical study is to compare the efficacy of subepithelial connective tissue graft harvested from the maxillary retromolar tubeosity area and L-PRF membranes in the treatment of RT1 recessions by coronally advanced flap.
A total of 30 patients will be recruited and randomly assigned to the test group treated with CAF+tSCTG or the control group treated with (CAF+L-PRF). For each experimental site the parameters of gingival recession (GR), pocket depth (PD), clinical attachment level (CAL), keratinized gingiva width (KT) and gingival thickness (GT) will be analyzed at baseline (T0) and at 12 months after the surgical procedure (T1). In addition, was also evaluated the different morbidity of the two surgical techniques, using the VAS scale values recorded in the first 2 weeks following surgery. It was checked the Patient Related Esthetic Score and Dentine hypersensivite reduction.
- Conditions
- Gingival Recession
- Being tested
- Periodontal surgery with CAF+tSCTG, Periodontal surgery with CAF+L-PRF
- Keywords
- Root coverage, Periodontal plastic surgery
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal surgery with CAF+tSCTGProcedure or surgery
Coronally advanced flap and subepithelial connective tissue graft harvested from the maxillary tuberosity area.
Periodontal surgery with CAF+L-PRFProcedure or surgery
Coronally advanced flap and L-PRF membranes
| Study group | Role | What they receive |
|---|---|---|
| CAF+tSCTG | Experimental | 15 sites will be treated.The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm, 2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession.Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa.The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of the crest bone.A partial thickness dissection will be performed in the most apical portion of the flap until complete passivation of the flap is obtained.The harvesting of the epithelial-connective graft will be performed at the level of the maxillary tuberosity. The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones. Receives: Procedure: Periodontal surgery with CAF+tSCTG |
| CAF+L-PRF | Active comparator | 15 sites will be treated.The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm,2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession. Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa. The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of bone.A partial thickness dissection will be performed in the apical portion of the flap to obtain complete passivation.The L-PRF membranes will be realized centrifuged venous blood collected in two 10-ml sterile tubes at 3000 rpm for 10 minutes and squeezing the fibrin clot. L-PRF membranes will be superimposed to crete a double layer of about 2 mm thickness.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones. Receives: Procedure: Periodontal surgery with CAF+L-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival thickness
Gingival tissue thickness 2 mm apical to the recession
Measured: 12 months
Secondary outcomes (5)
Keratinized tissue height
Distance between gingival margin and Mucogingival Junction
Measured: 12 months
Gingival recession
Distance from cementoenamel junction and gingival margin
Measured: 12 months
Complete root coverage
Percentage of experimental sites that achieved complete root surface coverage.
Measured: 12 months
Clinical attachment level
Distance between cementoenamel junction(CEJ) and depth of the pocket
Measured: 12 months
Pocket depth
Distance between gingival margin and bottom of the pocket
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 posted24 Mar 2023
- Study start13 Jun 2022
- Primary completion29 Oct 2023
- Study completion29 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783258
- Sponsor's protocol ID
- 13032023
- Status last verified
- Nov 2023
- First submitted
- 13 Mar 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Coronally Advanced Flap (CAF) Using a Connective Tissue Graft From the Tuberosity (tCTG) or L-PRF Membranes: a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05783258
- Acronym / sponsor ID
- 13032023
- Conditions
- Gingival Recession
- Keywords
- Root coverage, Periodontal plastic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 29 Oct 2023 (actual)
- Study completion
- 29 Oct 2023 (actual)
- First posted
- 24 Mar 2023 (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 aim of the present randomized controlled clinical study is to compare the efficacy of subepithelial connective tissue graft harvested from the maxillary retromolar tubeosity area and L-PRF membranes in the treatment of RT1 recessions by coronally advanced flap.
A total of 30 patients will be recruited and randomly assigned to the test group treated with CAF+tSCTG or the control group treated with (CAF+L-PRF). For each experimental site the parameters of gingival recession (GR), pocket depth (PD), clinical attachment level (CAL), keratinized gingiva width (KT) and gingival thickness (GT) will be analyzed at baseline (T0) and at 12 months after the surgical procedure (T1). In addition, was also evaluated the different morbidity of the two surgical techniques, using the VAS scale values recorded in the first 2 weeks following surgery. It was checked the Patient Related Esthetic Score and Dentine hypersensivite reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF+tSCTG | Experimental | Procedure: Periodontal surgery with CAF+tSCTG15 sites will be treated.The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm, 2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession.Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa.The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of the crest bone.A partial thickness dissection will be performed in the most apical portion of the flap until complete passivation of the flap is obtained.The harvesting of the epithelial-connective graft will be performed at the level of the maxillary tuberosity. The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones. |
| CAF+L-PRF | Active comparator | Procedure: Periodontal surgery with CAF+L-PRF15 sites will be treated.The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm,2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession. Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa. The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of bone.A partial thickness dissection will be performed in the apical portion of the flap to obtain complete passivation.The L-PRF membranes will be realized centrifuged venous blood collected in two 10-ml sterile tubes at 3000 rpm for 10 minutes and squeezing the fibrin clot. L-PRF membranes will be superimposed to crete a double layer of about 2 mm thickness.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Presence of a class RT1 recession;
- age > 18 years;
- systemic health conditions that do not affect the periodontium;
- Non smoker;
- FMPS and FMBS values < 20% before the surgical procedure;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Periodontal surgery with CAF+tSCTGCoronally advanced flap and subepithelial connective tissue graft harvested from the maxillary tuberosity area. | Procedure or surgery | CAF+tSCTG |
| Periodontal surgery with CAF+L-PRFCoronally advanced flap and L-PRF membranes | Procedure or surgery | CAF+L-PRF |
Primary outcome
Gingival thickness
Time frame: 12 months
Gingival tissue thickness 2 mm apical to the recession
5 secondary outcomes
Keratinized tissue height
Time frame: 12 months
Gingival recession
Time frame: 12 months
Complete root coverage
Time frame: 12 months
Clinical attachment level
Time frame: 12 months
Pocket depth
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 21 Nov 2023.
- 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 Periodontal surgery with CAF+tSCTG and Periodontal surgery with CAF+L-PRF 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 0 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 21 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?
Gingival thickness (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2023.