NCT04966208

Brief Summary

Coronally the advanced flap is considered a predictable treatment of gingival recession but in certain situations, it needs a filler like subperiosteal connective tissue graft (CTG) which is considered as the gold standard treatment approach. This randomized controlled trial compares the clinical benefits and effectiveness of a xenogenic collagen matrix (mucoderm, botiss, dental, Berlin, Germany) as a filler to the subperiosteal connective tissue graft (CTG).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

June 21, 2021

Last Update Submit

July 7, 2021

Conditions

Keywords

root coveragemucodermconnective tissuegrafts

Outcome Measures

Primary Outcomes (1)

  • The zone of keratinized gingiva

    The distance from the tip of the papilla to the mucogingival junction minus the probing depth measured in mm using graduated periodontal probe.

    6 months after the surgery

Secondary Outcomes (4)

  • Periodontal probing depth

    6 months after the surgery

  • Clinical attachment loss

    6 months after the surgery

  • Gingival recession

    6 months after the surgery

  • Patient satisfaction of the esthetics

    6 months

Study Arms (2)

root coverage surgeries using autologous connective tissue for treatment of gingival recession

ACTIVE COMPARATOR

root coverage surgeries using tunneling technique of autologous connective tissue as a treatment of Miller class two gingival recession

Procedure: xenogeneic collagen matrix

root coverage surgeries using xenogenic collagen matrix for treatment of gingival recession

EXPERIMENTAL

root coverage surgeries using tunneling technique of mucodrm membrane ; xenogeneic collagen matrix as a treatment of Miller class two gingival recession

Procedure: xenogeneic collagen matrix

Interventions

xenogeneic collagen matrix called mucoderm used for root coverage for treatment of gingival recession instead of harvesting from the patients connective tissue

root coverage surgeries using autologous connective tissue for treatment of gingival recessionroot coverage surgeries using xenogenic collagen matrix for treatment of gingival recession

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The selected patients for this study are non-smokers, aged 18-60 years with multiple gingival recession (Miller class 1, or 2.) for more than two adjacent affected teeth with plaque score less than 25%

You may not qualify if:

  • Patients with systemic complications, psychological problems, parafunctional habits, or patients presented with Mal-posed teeth, hypermobile teeth, teeth with Miller class 3 gingival recession were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71111111, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Periodontology and Oral Implantology-Faculty of Dentistry, Assiut University, Egypt.

Study Record Dates

First Submitted

June 21, 2021

First Posted

July 19, 2021

Study Start

September 1, 2020

Primary Completion

March 1, 2021

Study Completion

June 15, 2021

Last Updated

July 19, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations