NCT03162016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 23, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2020

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

May 15, 2017

Last Update Submit

March 20, 2026

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Percentage of Root coverage

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

    at 6 month

Secondary Outcomes (5)

  • postoperation pain

    at day 1 postoperation

  • postoperation pain

    at day 2 postoperation

  • postoperation pain

    at day 3 postoperation

  • postoperation pain

    at day 5 postoperation

  • postoperation pain

    at day 10 postoperation

Study Arms (2)

Transplants of acellular matrix

EXPERIMENTAL
Procedure: transplants

Transplants of connective tissue

ACTIVE COMPARATOR
Procedure: transplants

Interventions

transplantsPROCEDURE

Transplant of palatine tissue and transplant of connective tissue Mucoderm

Transplants of acellular matrixTransplants of connective tissue

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, France, 06000, France

Location

Related Publications (1)

  • 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.

    PMID: 33913631RESULT

MeSH Terms

Conditions

Gingival Recession

Interventions

Organ Transplantation

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 22, 2017

Study Start

June 23, 2017

Primary Completion

September 7, 2020

Study Completion

September 7, 2020

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)