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Completed

NCT Number: NCT02269748

Morbidity and Coverage Outcome With Connective Tissue Graft Used With Coronally Advanced Flap and Tunneling Technique

The aim of this randomized-controlled clinical trial is to compare the patient morbidity and root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with a coronally advanced flap (CAF) and tunnel technique (TT).

The primary objective of the study is to demonstrate the superiority in terms of the post-operative course and pain of the CAF+SeCTG when compared to the TT.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Padova

Padova, PD, 35122, Italy

About this study

The aim of this randomized-controlled clinical trial is to compare the patient morbidity and root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with a coronally advanced flap (CAF) and tunnel technique (TT).

The study will be designed as a single-centre, randomized, clinical trial on the treatment of single gingival recessions. The study assessed two different treatment modalities: the tunnel technique with subepithelial connective tissue graft (TT), compared to the coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) in terms of clinical outcomes, and post operative morbidity.

50 patients with one gingival recession each will be treated. Evaluation of patient morbidity will be performed 3 days and 1 week after the surgery. Clinical outcomes will be evaluated 12 months post operatively. Clinical outcomes included percentage of root coverage (RC) and complete root coverage (CRC) will be recorded. Patient morbidity will be evaluated with questionnaires.

Clinical measurements (1 week before surgery and at the 12 months follow-up)

  • Gingival recession height (GH)
  • Probing depth (PD)
  • Clinical attachment level (CAL)
  • Height of keratinized tissue (KTH)

Patient morbidity

  • Quantity of analgesics taken during the first week post-surgery.
  • Patients' post operative discomfort, bleeding, stress and inability to chew was evaluated with a questionnaire given to patients 3 days following surgery.

Kolmogorov-Smirnov test will be used to analyze distribution of continuous variables. Continuous variables are expressed as means ± standard deviation (SD) and compared at baseline by the U Mann-Whitney test. This test will be also used to compare mean changes post vs. baseline measurements. The Wilcoxon test will be used to compare post vs. baseline measurements. Spearman correlation will be used to evaluate associations.

Level of significance was set at 0.05. The SPSS v. 20 software (SPSS Inc., Chicago, IL, USA) will be used for all analyses.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Single Miller's Class I or Class II recession defects 2 to 4 mm range of recession height will be included presence of identifiable cemento enamel junction (CEJ) presence of a root abrasion, but with an identifiable CEJ, will be accepted; periodontally and systemically healthy no contraindications for periodontal surgery no taking medications known to interfere with periodontal tissue health or healing no periodontal surgery on the involved sites.

Exclusion criteria

Subjects smoking more than 10 cigarettes a day will be excluded. Recession defects associated with caries or restoration as well as teeth with evidence of a pulpal pathology will not be included.

Molar teeth will also be excluded.

Treatment and study plan

Tunnel technique with subepithelial connective tissue

Procedure

After harvesting a connective tissue graft from the palate, the graft is placed under a gingival tunnel prepared over the donor site.

Other names: root coverage procedure with tunnel technique

coronally advanced flap

Procedure

After harvesting a connective tissue graft from the palate, the graft is placed under a gingival flap which is repositioned coronally

Other names: Coronally advanced flap with sub epithelial connective tissue graft

Analgesic Therapy

Drug

Ibuprofen 600 mg TID

Primary outcomes

  1. Patient morbidity

    Time frame: 3 days after intervention

    Quantity of analgesics taken during the first week post-surgery. Patients' post operative discomfort, bleeding, stress and inability to chew was evaluated with a questionnaire given to patients 3 days following surgery.

Secondary outcomes

  1. Clinical measurements GH

    Time frame: 12 months follow-up

    Gingival recession height (GH)

  2. Clinical measurements PD

    Time frame: 12 months follow-up

    Probing depth (PD)

  3. Clinical measurements CAL

    Time frame: 12 months follow-up

    clinical attachment level (CAL)

  4. Clinical measurements KTH

    Time frame: 12 months follow-up

    height of keratinized tissue (KTH)

Sponsors and collaborators

Lead sponsor

University of Padova, School of Dental Medicine

Other

Registry information

Official study title

Patient Morbidity and Root Coverage Outcome After Subepithelial Connective Tissue Graft Used in Combination With Coronally Advanced Flap and Tunneling Technique: a Comparative Randomized Controlled Clinical Trial.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 21, 2014
Registry last updated
Oct 21, 2014

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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