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Completed

NCT Number: NCT02986191

The Use of Mucograft® to Treat Gingival Recession

Twenty patients with gingival recession will be enrolled in this trial. Gingival recession will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.

Patients will be followed for 3 and 6 months by measuring the clinical indexes and statistical analyses will be performed to compare the results and to assess the success of Mucograft®.

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Key information

Conditions

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

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

About this study

Many surgical techniques have used to treat gingival recession such aas repositioned flaps, autologous soft tissue grafts (connective tissue graft or free gingival grafts) or allografts like acellular dermal which can be used as substitutes for palatal donor tissue. Mucograft® (3D collagen matrix) is also an allograft from porcine origin and is designed for soft tissue regeneration and considered the ideal solution to autogenous soft tissue grafts and it provides an ideal matrix for blood vessel and soft tissue ingrowth.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presence of Type I or II (Miller Classification) of gingival recession

Exclusion criteria

  • Smoking
  • Pregnancy or lactating
  • Presence of any systematic diseases can affect the periodontal surgery.
  • Subjects with significant moderate to severe periodontal disease.
  • Patients under orthodontic treatment
  • Presence of restorative materials (e.g. crown)
  • Effectiveness of frenum
  • Subjects have failed to maintain good plaque control.
  • Subjects having previous surgical treatment for covering the recession in the chosen area.

Treatment and study plan

Mucograft

Procedure

This method of grafting will be used to treat the gingival recession using coronally advanced flaps.

connective tissue graft

Procedure

This will be used in the traditional manner to correct gingival recession

Primary outcomes

  1. Change in the Clinical Attachment Level Index

    Time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

    Clinical Attachment Level is dependent on measuring the pocket depth as well as the amount of gingival recession using specific tools. The measurement is going to be recorded in millimeters.

Secondary outcomes

  1. Change in Probing Depth

    Time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

    Probing depth is going to be measuring using a specific tool (UNC-15 probe).

  2. Change in Gingival Recession

    Time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

    Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.

  3. Change in Gingival Biotype

    Time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

    Gingival biotype is assessed by an endodontic file which used to determine the thickness of the gingival tissues (i.e. thick or thin).

  4. Change in Root Coverage Index

    Time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

    The amount of root exposure will be measured and compared to the total length of the root

  5. Change in Resistance to Muscular Pull

    Time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

    The cheeks or lips are going to be retracted by hand or by a mirror in order to see the movement of the free gingival tissues. The movement will be esitmated in millimeters.

  6. Change in Color Match Index

    Time frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

  7. Shrinkage index at three months

    Time frame: Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at three months exactly post-operatively.

  8. Shrinkage index at six months

    Time frame: Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at six months exactly post-operatively.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Clinical Applications of 3D Collagen Matrix (Mucograft®) in the Management of Gingival Recession: a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2016
Registry last updated
Feb 6, 2018

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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