Long-term Outcomes of Tunnel Technique

Completed

• Conditions: Recession, Gingival
• Interventions: Procedure: Connective tissue graft

• Registration Number: NCT04016493
• Lead Sponsor: University of Liege

Brief 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 with CTG.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-01
• Study Completion: 2019-01
• Study First Submitted: 2019-06-04
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-09
• Study First Posted: 2019-07-11
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Test group (TUN+CTG; N=20)	Connective tissue graft	-
Control group (CAF+CTG; N=20)	Connective tissue graft	-

Primary Outcome Measures

Name	Time	Method
Mean Root Coverage change	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
Plaque Index Change	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	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.
Gingival thickness change	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	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
Recession width change	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
PES Assessment change	Baseline, 6 months and 4 years	The PES was assessed according to the seven parameters described by Fürhauser (Fürhauser et al., 2005).

Secondary Outcome Measures

Name	Time	Method
Patient-related esthetic outcomes	4 years	(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).