Long-term Outcomes of Tunnel Technique

NCT04016493 | Completed

• 1 other identifier: H2011-1
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Recession, Gingival

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Patient-related esthetic outcomes

  4 years

Study Arms (2)

Control group (CAF+CTG; N=20)

Procedure: Connective tissue graft

Test group (TUN+CTG; N=20)

Procedure: Connective tissue graft

Interventions

Connective tissue graft PROCEDURE

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).

Control group (CAF+CTG; N=20); Test group (TUN+CTG; N=20)

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Liege: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: July 11, 2019
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2019
• Last Updated: July 11, 2019

Record last verified: 2019-07