Recession, GingivalNCT04016493
Long-term Outcomes of Tunnel Technique
An observational study of Recession, Gingival, run by University of Liege.
Trial summary
Few studies evaluate the outcomes beyond 1 year follow up for gingival recessions treatments using the tunnel technique in combination with connective tissue graft. The aim of this randomized controlled trial (RCT) was to compare the 4-year outcomes of the CAF versus the pouch/tunnel (TUN) technique both associated… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recession, Gingival
- What is being tested?
- Connective tissue graft
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2019
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Each patient (experimental unit) contributed a single recession. In cases of multiple recessions, the deepest one was included.
Who may be able to join
- Miller's class I recessions;
- Recession of 2 mm to 5 mm;
- Maxillary incisors, canines or premolars;
- Identifiable cementoenamel junction (CEJ);
- Patients minimum 18 years old;
- No/controlled periodontal disease;
- ASA1 or ASA2 (American Society of Anesthesiologists) general health status;
- Providing a signed informed consent form.
Who cannot join
- Smokers;
- Presence of cervical carious lesion;
- Pocket depth greater than 4 mm;
- Sites where previous muco-gingival therapy was performed;
- Pregnancy.
- In presence of non-carious cervical lesions, the anatomical CEJ was reconstructed by the use of a composite before the procedure.
About this study
Official title: Tunnel Versus Coronally Advanced Flap Combined With a Connective Tissue Graft for the Treatment of Gingival Recessions: Long Term (4 Years) Follow-up of a Randomized Controlled Trial
Few studies evaluate the outcomes beyond 1 year follow up for gingival recessions treatments using the tunnel technique in combination with connective tissue graft. The aim of this randomized controlled trial (RCT) was to compare the 4-year outcomes of the CAF versus the pouch/tunnel (TUN) technique both associated with CTG.
- Conditions
- Recession, Gingival
- Being tested
- 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.
Connective tissue graftProcedure or surgery
The patient received 600 mg of ibuprofen (paracetamol 1 g in case of allergy) prior to surgery, and chlorhexidine mouthwash 0.2% was provided for 2 min. Patients received local anaesthesia at the donor and recession sites (articaine hydrochloride 7200 mg/1.8 ml, adrenalin 1800 mcg/1.8 ml). CTG harvesting was performed prior to the preparation of the reception site to avoid any bias. The graft dimension was calculated according to the recession dimensions; a minimum of 3 mm of the graft was submerged mesially, distally and apically. The CTG was harvested from the palate with single edge incision and sutured with 4.0 silk. The patient was subsequently assigned randomly to the control (CAF+CTG) or the test group (TUN+CTG).
| Study group | Role | What they receive |
|---|---|---|
| Control group (CAF+CTG; N=20) | Not described Receives: Procedure: Connective tissue graft | |
| Test group (TUN+CTG; N=20) | Not described Receives: Procedure: Connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index Change
The plaque accumulation is assessed at baseline, 6 months and 4 years follow-up visits using a 0-1 scoring system, 0 being the the highest value, 1 being the lowest result (0 =No detectible plaque ; 1 = Plaque can be seen by the naked eye)
Measured: baseline, 6 months and 4 years
Bleeding on probing score change
The bleeding tendency is assessed at baseline, 6 months and 4 years follow-up visits as : 0 No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant; 1 Isolated bleeding spots visible ; 2 Blood forms a confluent red line on the margin; 3 Heavy or profuse bleeding.
Measured: baseline, 6 months and 4 years
Recession width change
The status of the recession width was recorded at baseline, 6 months and 4 years follow-up visits.
The scale is in mm. More large is it, worst it is Minest large it is, best it is
Measured: baseline, 6 months and 4 years
Gingival thickness change
The gingival thickness was recorded at baseline, 6 months and 4 years follow-up visits.
The scale is in mm. More thick is it, best it is Minest thick it is, worst it is
Measured: baseline, 6 months and 4 years
Keratinised mucosa height change
The status of the keratinised mucosa height was recorded at baseline, 6 months and 4 years follow-up visits.
The scale is in mm. More large is it, best it is Minest large it is, worst it is
Measured: baseline, 6 months and 4 years
Mean Root Coverage change
The status of the Mean Root Coverage was recorded at 6 months and 4 years follow-up visits.
The scale is in mm. More long it is, best it is Minest long it is, worst it is
Measured: at 6 months and 4 years.
PES Assessment change
The PES was assessed according to the seven parameters described by Fürhauser (Fürhauser et al., 2005).
Measured: Baseline, 6 months and 4 years
Secondary outcomes (1)
Patient-related esthetic outcomes
(Fürhauser et al., 2005). Patient-related esthetic outcomes were also recorded in a questionnaire using a 0-14 graduated scale (0 being the worst and 14 the best value).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recession, GingivalStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. France LAMBERT, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016493
- Sponsor's protocol ID
- H2011-1
- Status last verified
- Jul 2019
- First submitted
- 4 Jun 2019
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tunnel Versus Coronally Advanced Flap Combined With a Connective Tissue Graft for the Treatment of Gingival Recessions: Long Term (4 Years) Follow-up of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04016493
- Acronym / sponsor ID
- H2011-1
- Conditions
- Recession, Gingival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 11 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.
Few studies evaluate the outcomes beyond 1 year follow up for gingival recessions treatments using the tunnel technique in combination with connective tissue graft. The aim of this randomized controlled trial (RCT) was to compare the 4-year outcomes of the CAF versus the pouch/tunnel (TUN) technique both associated with CTG.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (CAF+CTG; N=20) | – | Procedure: Connective tissue graft |
| Test group (TUN+CTG; N=20) | – | Procedure: Connective tissue graft |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Each patient (experimental unit) contributed a single recession. In cases of multiple recessions, the deepest one was included.
Key inclusion criteria (8 listed)
- Miller's class I recessions;
- Recession of 2 mm to 5 mm;
- Maxillary incisors, canines or premolars;
- Identifiable cementoenamel junction (CEJ);
- Patients minimum 18 years old;
Key exclusion criteria (6 listed)
- Smokers;
- Presence of cervical carious lesion;
- Pocket depth greater than 4 mm;
- Sites where previous muco-gingival therapy was performed;
- Pregnancy.
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 |
|---|---|---|
| Connective tissue graftThe patient received 600 mg of ibuprofen (paracetamol 1 g in case of allergy) prior to surgery, and chlorhexidine mouthwash 0.2% was provided for 2 min. Patients received local anaesthesia at the donor and recession sites (articaine hydrochloride 7200 mg/1.8 ml, adrenalin 1800 mcg/1.8 ml). CTG harvesting was performed prior to the preparation of the reception site to avoid any bias. The graft dimension was calculated according to the recession dimensions; a minimum of 3 mm of the graft was submerged mesially, distally and apically. The CTG was harvested from the palate with single edge incision and sutured with 4.0 silk. The patient was subsequently assigned randomly to the control (CAF+CTG) or the test group (TUN+CTG). | Procedure or surgery | Control group (CAF+CTG; N=20), Test group (TUN+CTG; N=20) |
Primary outcome
Plaque Index Change
Time frame: baseline, 6 months and 4 years
The plaque accumulation is assessed at baseline, 6 months and 4 years follow-up visits using a 0-1 scoring system, 0 being the the highest value, 1 being the lowest result (0 =No detectible plaque ; 1 = Plaque can be seen by the naked eye)
Bleeding on probing score change
Time frame: baseline, 6 months and 4 years
The bleeding tendency is assessed at baseline, 6 months and 4 years follow-up visits as : 0 No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant; 1 Isolated bleeding spots visible ; 2 Blood forms a confluent red line on the margin; 3 Heavy or profuse bleeding.
Recession width change
Time frame: baseline, 6 months and 4 years
The status of the recession width was recorded at baseline, 6 months and 4 years follow-up visits. The scale is in mm. More large is it, worst it is Minest large it is, best it is
Gingival thickness change
Time frame: baseline, 6 months and 4 years
The gingival thickness was recorded at baseline, 6 months and 4 years follow-up visits. The scale is in mm. More thick is it, best it is Minest thick it is, worst it is
Keratinised mucosa height change
Time frame: baseline, 6 months and 4 years
The status of the keratinised mucosa height was recorded at baseline, 6 months and 4 years follow-up visits. The scale is in mm. More large is it, best it is Minest large it is, worst it is
Mean Root Coverage change
Time frame: at 6 months and 4 years.
The status of the Mean Root Coverage was recorded at 6 months and 4 years follow-up visits. The scale is in mm. More long it is, best it is Minest long it is, worst it is
PES Assessment change
Time frame: Baseline, 6 months and 4 years
The PES was assessed according to the seven parameters described by Fürhauser (Fürhauser et al., 2005).
1 secondary outcome
Patient-related esthetic outcomes
Time frame: 4 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 11 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Recession, Gingival
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Recruiting
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Recession, Gingival, run by University of Liege.
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 8 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: finished, as of the sponsor's last update on 11 Jul 2019. 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?
Plaque Index Change (time frame: baseline, 6 months and 4 years). The study lists 7 primary outcomes in all. 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 11 Jul 2019.