Long-term Outcomes of Tunnel Technique

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.

Study Overview

• Status: Completed
• Conditions: Recession, Gingival
• Intervention / Treatment: Procedure: Connective tissue graft

• Study Type: Observational
• Enrollment (Actual): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Each patient (experimental unit) contributed a single recession. In cases of multiple recessions, the deepest one was included.

Description

Inclusion Criteria:

• 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.

Exclusion criteria were:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group (CAF+CTG; N=20)	Procedure: Connective tissue graft; 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).
Test group (TUN+CTG; N=20)	Procedure: Connective tissue graft; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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	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	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	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	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).	Baseline, 6 months and 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	4 years

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: H2011-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No