Long-term Outcomes of Tunnel Technique

Recession, Gingival Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016493
• Other study ID #: H2011-1
• Status: Completed
• Start date: January 2013
• Est. completion date: January 2019

Study information

• Verified date: July 2019
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 with CTG.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2019
• Est. primary completion date: January 2014
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession
• Recession, Gingival

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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	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