Gingival Recession Localized ModerateNCT06135662
Comparing Tunnel Technique and CAF With CTG in Mandibular Gingival Recession Treatment
A study testing CAF + CTG and Tunnel Technique + CTG in people with Gingival Recession Localized Moderate, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of two different surgical techniques, the Coronally Advanced Flap (CAF) and the Tunnel Technique (TT) with Connective Tissue Grafts (CTG), in treating mandibular gingival recession. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession Localized Moderate
- What is being tested?
- CAF + CTG and Tunnel Technique + CTG
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 11 Dec 2023to 10 Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years; periodontally and systemically healthy
- presence of RT1 and RT2 gingival recession defects
- recession in the mandibular arch
- recession ≥ 2mm in depth at the buccal aspect
- full-mouth plaque and bleeding score ≤ 20%
- no previous periodontal surgery
- presence of identifiable cemento-enamel junction (CEJ) (a step ≤1mm at the CEJ and/or presence of root abrasion, but with identifiable CEJ, will be accepted).
Who cannot join
- smokers ≥10 cigarettes a day
- contraindications for periodontal surgery
- medications known to affect the gingiva or interfere with wound healing
- pregnancy
- active orthodontic therapy
- caries or restorations in the area to be treated
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
UIC Barcelona - Clinica Universitaria de Odontologia
Sant Cugat del Vallès, Barcelona, 08195
UIC Universidad Internacional de Catalunya, 935042030, clinica@uic.es
About this study
Official title: Tunnel Technique Versus Coronally Advanced Flap Combined With a Connective Tissue Graft for the Treatment of Mandibular Gingival Recessions: A Randomized Clinical Trial
The goal of this clinical trial is to evaluate the effectiveness of two different surgical techniques, the Coronally Advanced Flap (CAF) and the Tunnel Technique (TT) with Connective Tissue Grafts (CTG), in treating mandibular gingival recession. This study, focusing on healthy patients with RT1 and RT2 gingival recessions, aims to determine which surgical approach offers better root coverage for mandibular recession defects. Additionally, it seeks to understand the effects of these techniques on aspects such as keratinized tissue gain, vestibular depth, gingival thickness, and patient-reported outcomes. Participants in this trial will undergo one of the two surgical procedures and are expected to attend a total of six assessment visits. Researchers will compare the results from both groups, those treated with CAF and those with TT+CTG, to discern if one method is superior in achieving more effective root coverage, enhanced aesthetic appearance, and reduced discomfort associated with gingival recession.
Read the detailed description
This clinical trial is designed to rigorously assess the effectiveness of two surgical techniques, the Coronally Advanced Flap (CAF) and the Tunnel Technique (TT) with Connective Tissue Grafts (CTG), in the treatment of mandibular gingival recession, specifically targeting RT1 and RT2 types of recessions. The primary objective of this study is to determine which of these approaches provides superior root coverage in managing mandibular recession defects. The secondary objectives include evaluating the impact of these treatments on keratinized tissue gain, changes in vestibular depth, variations in gingival thickness, and patient-reported outcomes such as pain and aesthetic satisfaction.
Healthy participants diagnosed with mandibular gingival recession will be enrolled and randomly assigned to undergo either the CAF or TT+CTG surgical procedure. The study will follow a structured timeline with a total of six assessment visits for each participant, scheduled at key intervals: 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation. These time points are chosen to effectively monitor both the immediate and the long-term results of the treatments.
The primary outcome measure, Mean Root Coverage (MRC), will be evaluated at each follow-up visit to quantify the extent of root coverage achieved by the respective surgical techniques. Secondary outcome measures include the assessment of Vestibular Depth (VD), Complete Root Coverage (CRC), changes in Keratinized Tissue Width (KT), and changes in Gingival Thickness (GT). These measures will provide a comprehensive understanding of the physiological and aesthetic impacts of the surgical interventions.
By comparing the outcomes from both treatment groups, the study aims to provide clear evidence on the effectiveness of CAF versus TT+CTG in treating mandibular gingival recession, guiding future clinical decisions and patient care strategies in periodontology.
- Conditions
- Gingival Recession Localized Moderate
- Being tested
- CAF + CTG, Tunnel Technique + CTG
- Keywords
- RT1, RT2, CAF, Tunnel Technique, Connective Tissue Graft, Gingival Recessions, CTG
- 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 + CTGProcedure or surgery
Surgical techniques for mandibular gingival recession: coronally advanced flap + connective tissue graft. Participants undergo initial evaluations, including periodontal exams and digital imaging, followed by standardized pre-operative preparations. Post-surgery, uniform care includes pain management and oral hygiene instructions, with follow-ups to monitor healing and assess outcomes. Primary and secondary outcomes, like root coverage and patient-reported satisfaction, are consistently measured across groups. Standardized data collection and analysis procedures ensure reliable, comparable results, facilitating an effective comparison of the surgical methods' efficacy.
Tunnel Technique + CTGProcedure or surgery
Surgical techniques for mandibular gingival recession: tunnel technique + connective tissue graft. Participants undergo initial evaluations, including periodontal exams and digital imaging, followed by standardized pre-operative preparations. Post-surgery, uniform care includes pain management and oral hygiene instructions, with follow-ups to monitor healing and assess outcomes. Primary and secondary outcomes, like root coverage and patient-reported satisfaction, are consistently measured across groups. Standardized data collection and analysis procedures ensure reliable, comparable results, facilitating an effective comparison of the surgical methods' efficacy.
| Study group | Role | What they receive |
|---|---|---|
| CAF + CTG | Active comparator | This arm involves patients treated with the Coronally Advanced Flap (CAF) technique, a recognized method for treating gingival recession. As an active comparator, this arm serves to compare the effectiveness and outcomes of CAF against the alternative surgical method used in the study. Receives: Procedure: CAF + CTG |
| Tunnel Technique + CTG | Active comparator | Patients in this arm receive the Tunnel Technique (TT) with Connective Tissue Grafts (CTG). Also an established method for gingival recession treatment, this arm acts as an active comparator to assess and compare the effectiveness of TT+CTG against the CAF technique. Receives: Procedure: Tunnel Technique + CTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Root Coverage (MRC)
he Mean Root Coverage measures the percentage of exposed tooth root that has been covered by gum tissue after surgery, compared to before the treatment.
Measured: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
Secondary outcomes (4)
Vestibular depth (VD)
Measurement of the depth of the vestibular area (the space between the inside of the lip/cheek and the gum) to assess changes post-surgery.
Measured: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
Complete Root Coverage (CRC)
Assessment of whether the entire exposed root surface is covered by gum tissue post-treatment.
Measured: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
change in Keratinized Tissue Width (KT)
Measurement of the width of keratinized tissue (gum tissue that is firmly attached to the bone) to note any changes following the surgical procedure.
Measured: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
change in gingival thickness (GT)
Assessment of the thickness of the gum tissue to evaluate changes after surgery.
Measured: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start11 Dec 2023
- Primary completion10 Apr 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession Localized ModerateStudies 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
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonzalo Blasi, Universitat Internacional de Catalunya
- Investigators
- Gonzalo Blasi, DDS MS, Principal investigator, UIC Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135662
- Sponsor's protocol ID
- PER-ECL-2023-01
- Status last verified
- Mar 2024
- First submitted
- 12 Nov 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zucchelli G, De Sanctis M. Treatment of multiple recession-type defects in patients with esthetic demands. J Periodontol. 2000 Sep;71(9):1506-14. doi: 10.1902/jop.2000.71.9.1506.
PubMed 11022782Cairo F, Nieri M, Cattabriga M, Cortellini P, De Paoli S, De Sanctis M, Fonzar A, Francetti L, Merli M, Rasperini G, Silvestri M, Trombelli L, Zucchelli G, Pini-Prato GP. Root coverage esthetic score after treatment of gingival recession: an interrater agreement multicenter study. J Periodontol. 2010 Dec;81(12):1752-8. doi: 10.1902/jop.2010.100278. Epub 2010 Jul 14.
PubMed 20629546
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tunnel Technique Versus Coronally Advanced Flap Combined With a Connective Tissue Graft for the Treatment of Mandibular Gingival Recessions: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06135662
- Acronym / sponsor ID
- PER-ECL-2023-01
- Conditions
- Gingival Recession Localized Moderate
- Keywords
- RT1, RT2, CAF, Tunnel Technique, Connective Tissue Graft, Gingival Recessions, CTG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 18 Nov 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 goal of this clinical trial is to evaluate the effectiveness of two different surgical techniques, the Coronally Advanced Flap (CAF) and the Tunnel Technique (TT) with Connective Tissue Grafts (CTG), in treating mandibular gingival recession. This study, focusing on healthy patients with RT1 and RT2 gingival recessions, aims to determine which surgical approach offers better root coverage for mandibular recession defects. Additionally, it seeks to understand the effects of these techniques on aspects such as keratinized tissue gain, vestibular depth, gingival thickness, and patient-reported outcomes. Participants in this trial will undergo one of the two surgical procedures and are expected to attend a total of six assessment visits. Researchers will compare the results from both groups, those treated with CAF and those with TT+CTG, to discern if one method is superior in achieving more effective root coverage, enhanced aesthetic appearance, and reduced discomfort associated with gingival recession.
Detailed description
This clinical trial is designed to rigorously assess the effectiveness of two surgical techniques, the Coronally Advanced Flap (CAF) and the Tunnel Technique (TT) with Connective Tissue Grafts (CTG), in the treatment of mandibular gingival recession, specifically targeting RT1 and RT2 types of recessions. The primary objective of this study is to determine which of these approaches provides superior root coverage in managing mandibular recession defects. The secondary objectives include evaluating the impact of these treatments on keratinized tissue gain, changes in vestibular depth, variations in gingival thickness, and patient-reported outcomes such as pain and aesthetic satisfaction.
Healthy participants diagnosed with mandibular gingival recession will be enrolled and randomly assigned to undergo either the CAF or TT+CTG surgical procedure. The study will follow a structured timeline with a total of six assessment visits for each participant, scheduled at key intervals: 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation. These time points are chosen to effectively monitor both the immediate and the long-term results of the treatments.
The primary outcome measure, Mean Root Coverage (MRC), will be evaluated at each follow-up visit to quantify the extent of root coverage achieved by the respective surgical techniques. Secondary outcome measures include the assessment of Vestibular Depth (VD), Complete Root Coverage (CRC), changes in Keratinized Tissue Width (KT), and changes in Gingival Thickness (GT). These measures will provide a comprehensive understanding of the physiological and aesthetic impacts of the surgical interventions.
By comparing the outcomes from both treatment groups, the study aims to provide clear evidence on the effectiveness of CAF versus TT+CTG in treating mandibular gingival recession, guiding future clinical decisions and patient care strategies in periodontology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF + CTG | Active comparator | Procedure: CAF + CTGThis arm involves patients treated with the Coronally Advanced Flap (CAF) technique, a recognized method for treating gingival recession. As an active comparator, this arm serves to compare the effectiveness and outcomes of CAF against the alternative surgical method used in the study. |
| Tunnel Technique + CTG | Active comparator | Procedure: Tunnel Technique + CTGPatients in this arm receive the Tunnel Technique (TT) with Connective Tissue Grafts (CTG). Also an established method for gingival recession treatment, this arm acts as an active comparator to assess and compare the effectiveness of TT+CTG against the CAF technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years; periodontally and systemically healthy
- presence of RT1 and RT2 gingival recession defects
- recession in the mandibular arch
- recession ≥ 2mm in depth at the buccal aspect
- full-mouth plaque and bleeding score ≤ 20%
Key exclusion criteria (6 listed)
- smokers ≥10 cigarettes a day
- contraindications for periodontal surgery
- medications known to affect the gingiva or interfere with wound healing
- pregnancy
- active orthodontic therapy
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 + CTGSurgical techniques for mandibular gingival recession: coronally advanced flap + connective tissue graft. Participants undergo initial evaluations, including periodontal exams and digital imaging, followed by standardized pre-operative preparations. Post-surgery, uniform care includes pain management and oral hygiene instructions, with follow-ups to monitor healing and assess outcomes. Primary and secondary outcomes, like root coverage and patient-reported satisfaction, are consistently measured across groups. Standardized data collection and analysis procedures ensure reliable, comparable results, facilitating an effective comparison of the surgical methods' efficacy. | Procedure or surgery | CAF + CTG |
| Tunnel Technique + CTGSurgical techniques for mandibular gingival recession: tunnel technique + connective tissue graft. Participants undergo initial evaluations, including periodontal exams and digital imaging, followed by standardized pre-operative preparations. Post-surgery, uniform care includes pain management and oral hygiene instructions, with follow-ups to monitor healing and assess outcomes. Primary and secondary outcomes, like root coverage and patient-reported satisfaction, are consistently measured across groups. Standardized data collection and analysis procedures ensure reliable, comparable results, facilitating an effective comparison of the surgical methods' efficacy. | Procedure or surgery | Tunnel Technique + CTG |
Primary outcome
Mean Root Coverage (MRC)
Time frame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
he Mean Root Coverage measures the percentage of exposed tooth root that has been covered by gum tissue after surgery, compared to before the treatment.
4 secondary outcomes
Vestibular depth (VD)
Time frame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
Complete Root Coverage (CRC)
Time frame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
change in Keratinized Tissue Width (KT)
Time frame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
change in gingival thickness (GT)
Time frame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 11022782Zucchelli G, De Sanctis M. Treatment of multiple recession-type defects in patients with esthetic demands. J Periodontol. 2000 Sep;71(9):1506-14. doi: 10.1902/jop.2000.71.9.1506.
- Results publication: PubMed 20629546Cairo F, Nieri M, Cattabriga M, Cortellini P, De Paoli S, De Sanctis M, Fonzar A, Francetti L, Merli M, Rasperini G, Silvestri M, Trombelli L, Zucchelli G, Pini-Prato GP. Root coverage esthetic score after treatment of gingival recession: an interrater agreement multicenter study. J Periodontol. 2010 Dec;81(12):1752-8. doi: 10.1902/jop.2010.100278. Epub 2010 Jul 14.
- 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.
Gonzalo Blasi, DDS MS principal investigator
UIC Barcelona
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 Tunnel Technique + CTG in people with Gingival Recession Localized Moderate, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 6 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: status not confirmed, as of the sponsor's last update on 8 Mar 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gonzalo Blasi, DDS MS (+34 620387688, gonzaloblasi@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Root Coverage (MRC) (time frame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation). 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 NCT06135662, which also lists 2 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 8 Mar 2024; AzTrials last refreshed its copy on 3 Nov 2026.