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Completed

NCT Number: NCT04016493

Long-term Outcomes of Tunnel Technique

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.

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Key information

Conditions

Recession, Gingival Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Plaque Index Change

    Time frame: 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)

  2. Bleeding on probing score change

    Time frame: 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.

  3. Recession width change

    Time frame: 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

  4. Gingival thickness change

    Time frame: 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

  5. Keratinised mucosa height change

    Time frame: 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

  6. Mean Root Coverage change

    Time frame: 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

  7. PES Assessment change

    Time frame: Baseline, 6 months and 4 years

    The PES was assessed according to the seven parameters described by Fürhauser (Fürhauser et al., 2005).

Secondary outcomes

  1. Patient-related esthetic outcomes

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2019
First posted
Jul 11, 2019
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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