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

Gingival Recession Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162016
• Other study ID #: 16-PP-07
• Status: Completed
• Phase: N/A
• Start date: June 23, 2017
• Est. completion date: September 7, 2020

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 7, 2020
• Est. primary completion date: September 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• transplants
Transplant of palatine tissue and transplant of connective tissue Mucoderm

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Root coverage	Comparison of Percentage of Root coverage at baseline and 6 months postoperatively	at 6 month
Secondary	postoperation pain	visual analogic scale (at control and test side),	at day 1 postoperation
Secondary	postoperation pain	visual analogic scale (at control and test side),	at day 2 postoperation
Secondary	postoperation pain	visual analogic scale (at control and test side),	at day 3 postoperation
Secondary	postoperation pain	visual analogic scale (at control and test side),	at day 5 postoperation
Secondary	postoperation pain	visual analogic scale (at control and test side),	at day 10 postoperation