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OpenTrials
Completed

NCT Number: NCT03162016

Treatment Off Gingival Recession Defects Using a Xenogenic Acellular Dermal Matrix Compared to Connective Tissue Graft.

Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft harvesting. We want to show if mucoderm used in tunnel technique to recover miller class I and II recessions defects could be an alternative to connective tissue graft.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, France, 06000

About this study

Connective tissue graft harvested from the palate does not always have sufficient size to cover multiple recession defects. Moreover, connective tissue graft shows significant postoperative morbidity to treat generalized multiple gingival recessions. The goal of this study is to show if Mucoderm could be considered has a substitute of connective tissue graft in the coverage of gingival recession defects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients > 45 years, postmenopausal women (ie with amenorrhea for more than a year).
  • Subject with bilateral Miller class I or II recessions defects
  • non smoking patients
  • patients having read and understood the information note on the study and signed the informed consent form.
  • patients affiliated to the social security system.

Exclusion criteria

  • Patient with absolute contra-indication for dental surgery: valvular heart disease at risk of infectious endocarditis, recent myocardal (≤ 12 months), organ transplants, recent placement of a coronary stent (≤ 12 months), transient ischemic attacks recurrent, cardiovascular instability, uncontrolled epilepsy, rheumatic fever.
  • Patient with metabolic bone disease (Paget's disease, osteomalacia, osteogenesis imperfecta)
  • Patient with an ASA score ≥ 3.
  • Patient with absolute contra-indication to dental surgery
  • Patient with severe hematologic disease
  • Patient with I or type II diabetes
  • Patients with previous or current acute illness or severe chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, neuro-psychiatric, considered by the investigator to be incompatible with the conduct of the study.
  • Patients treated with retinoids, oral bisphosphonates, oral anticoagulants or anticonvulsants.
  • Patient have or have had cancer of the upper aerodigestive tract treated by radiotherapy.
  • Patient taking a steroidal or non-steroidal anti-inflammatory, anti-cancer or immunosuppressive chemotherapy in the last 6 months.
  • Patient monitoring considered difficult by the investigator.
  • Patient with poor oral hygiene incompatible with oral surgery.
  • Patients with periodontal disease unstabilized
  • Patient with oral dermatitis or adverse occlusion.
  • Patient with an acute or chronic infection of the surgical site (osteomyelitis).
  • Patient with a known allergy to collagen
  • Patient with autoimmune disease
  • Patient with a linguistic or mental incapacity to understand information
  • Patient younger than 45 years old
  • Patient trust under curatorship or judicial protection
  • Patients aged over 45 premenopausal.
  • Patient participating in another clinical study.

Treatment and study plan

transplants

Procedure

Transplant of palatine tissue and transplant of connective tissue Mucoderm

Primary outcomes

  1. Percentage of Root coverage

    Time frame: at 6 month

    Comparison of Percentage of Root coverage at baseline and 6 months postoperatively

Secondary outcomes

  1. postoperation pain

    Time frame: at day 1 postoperation

    visual analogic scale (at control and test side),

  2. postoperation pain

    Time frame: at day 2 postoperation

    visual analogic scale (at control and test side),

  3. postoperation pain

    Time frame: at day 3 postoperation

    visual analogic scale (at control and test side),

  4. postoperation pain

    Time frame: at day 5 postoperation

    visual analogic scale (at control and test side),

  5. postoperation pain

    Time frame: at day 10 postoperation

    visual analogic scale (at control and test side),

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Treatment of Multiple Gingival Recession Defects Using a Xenogenic Acellular Dermal Matrix Compared to Connective Tissue Graft: a Randomized Controlled Clinical Study

Acronym: MUCODERM

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 22, 2017
Registry last updated
Mar 24, 2026

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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