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

Primary Purpose

Gingival Recession

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

transplants

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHU de Nice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transplants of acellular matrix

Transplants of connective tissue

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Root coverage

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

Secondary Outcome Measures

postoperation pain

visual analogic scale (at control and test side),

postoperation pain

visual analogic scale (at control and test side),

postoperation pain

visual analogic scale (at control and test side),

postoperation pain

visual analogic scale (at control and test side),

postoperation pain

visual analogic scale (at control and test side),

Full Information

NCT ID

NCT03162016

First Posted

May 15, 2017

Last Updated

May 22, 2017

Sponsor

Centre Hospitalier Universitaire de Nice

1. Study Identification

Unique Protocol Identification Number

NCT03162016

Brief Title

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

Acronym

MUCODERM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 18, 2017 (Actual)

Primary Completion Date

May 18, 2018 (Anticipated)

Study Completion Date

November 18, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transplants of acellular matrix

Arm Type

Experimental

Arm Title

Transplants of connective tissue

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

transplants

Intervention Description

Transplant of palatine tissue and transplant of connective tissue Mucoderm

Primary Outcome Measure Information:

Title

Percentage of Root coverage

Description

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

Time Frame

at 6 month

Secondary Outcome Measure Information:

Title

postoperation pain

Description

visual analogic scale (at control and test side),

Time Frame

at day 1 postoperation

Title

postoperation pain

Description

visual analogic scale (at control and test side),

Time Frame

at day 2 postoperation

Title

postoperation pain

Description

visual analogic scale (at control and test side),

Time Frame

at day 3 postoperation

Title

postoperation pain

Description

visual analogic scale (at control and test side),

Time Frame

at day 5 postoperation

Title

postoperation pain

Description

visual analogic scale (at control and test side),

Time Frame

at day 10 postoperation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

CHU de Nice

City

Nice

ZIP/Postal Code

06000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33913631

Citation

Vincent-Bugnas S, Laurent J, Naman E, Charbit M, Borie G. Treatment of multiple gingival recessions with xenogeneic acellular dermal matrix compared to connective tissue graft: a randomized split-mouth clinical trial. J Periodontal Implant Sci. 2021 Apr;51(2):77-87. doi: 10.5051/jpis.2002400120.

Results Reference

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

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