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NCT Number: NCT02632240

Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions

The aim of this study is to compare the efficacy of dental root coverage using the tunnel technique with connective tissue graft (CTG) and the same technique with collagen matrix for treatment of multiple gingival recessions Miller Class I and II.

This study is a randomized-controlled clinical trial of 6 months duration.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontal and Oral Mucosa Diseases

Zabrze, 41-800, Poland

About this study

According to the medical databases, there are limited randomized clinical trials comparing xenogenic collagen matrix and CTG used with the tunnel technique. The collagen matrix is a possible alternative to connective tissue graft.

The purpose of this clinical study is to compare short-term (3-6 months) outcomes of a root coverage using the tunnel technique with the collagen matrix and the same technique with CTG for the treatment of multiple recessions Miller class I and II.

Twenty eight patients are enrolled in the study. Patients in the test group are treated with xenogenic collagen matrix using the tunnel technique whereas patients in the control group with CTG. Clinical recordings are obtained at baseline and after 3 and 6 months. The percentage of average recession coverage (ARC) is evaluated after 3 and 6 months after the surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presence of minimum two adjacent periodontal recessions Miller class I or II and at least 2 mm recessions depth.

Exclusion criteria

  • Approximal Plaque Index (API) > 15%,
  • Sulcus Bleeding Index (SBI) > 10%,
  • Systemic diseases with compromised healing potential or infectious diseases,
  • Untreated periodontal conditions,
  • Pregnant and lactating females.

Treatment and study plan

Surgery:The tunnel technique for covering gingival recession

Other

The surgery starts with the sulcular incisions in the region of recessions, which enable access for the supraperiosteal preparation. The procedure is extended into the mucosal tissue using the tunneling knives. The partial-thickness flap is performed at the buccal site. Only the papillary regions are fully detached with the periosteum. The graft is placed into the tunnel and stabilized with absorbable sutures.The mobilized mucous flap is advanced coronally and stabilized with non-absorbable suspensory sutures.

Primary outcomes

  1. Clinical attachment level (CAL)

    Time frame: 6 months

    Distance from the cemento enamel junction to the deepest point of the gingival sulcus

Secondary outcomes

  1. Recession depth (RD)

    Time frame: 6 months

    Distance from the mid-facial point of the cemento-enamel junction to the free gingival margin

  2. Recession width (RW)

    Time frame: 6 months

    Recession width horizontally at cemento-enamel junction level

  3. Width of keratinized tissue (KTW)

    Time frame: 6 months

    Distance from the mucogingival junction to the gingival margin

  4. Recession area (RA)

    Time frame: 6 months

    The area of a triangle with a width of recession as the base and a depth of the recession as the height.

  5. the average percentage of root coverage (ARC)

    Time frame: 6 months

    The percentage of covered recession area.

  6. The complete coverage of recessions (CRC)

    Time frame: 6 months

    The percentage rate of patients with complete coverage of all recessions (CRC)

Other outcomes

  1. The depth of gingival sulcus (PD)

    Time frame: 6 months

    Distance from the gingival margin to the deepest point of gingival sulcus

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions - Randomized Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 16, 2015
Registry last updated
Dec 18, 2015

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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