Long-term Outcomes of Tunnel Technique

NCT ID: NCT04016493

Last Updated: 2019-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2019-01-31

Brief Summary

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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

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Conditions

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Recession, Gingival

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group (CAF+CTG; N=20)

Connective tissue graft

Intervention Type 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).

Test group (TUN+CTG; N=20)

Connective tissue graft

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Dr. France LAMBERT

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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H2011-1

Identifier Type: -

Identifier Source: org_study_id

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