NCT05956496

Brief Summary

This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing root coverage for gingival recession will be enrolled.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

July 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 3, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

July 13, 2023

Last Update Submit

April 9, 2024

Conditions

Gingival Recession

Keywords

Gingival augmentationGraft materialsAcellular dermal matrix (ADM)Subepithelial connective tissue graft (SCTG)

Outcome Measures

Primary Outcomes (2)

  • Percentage root coverage

    Measured as change in percentage root coverage

    Baseline to 12 months

  • Keratinized tissue width

    Measured as change in keratinized tissue width

    Baseline to 12 months

Study Arms (2)

Control Group: Acellular Dermal Matrix - Superficial cut (ADM-S)

PLACEBO COMPARATOR

A commonly used allograft material is the Acellular Dermal Matrix (ADM) which is harvested from human donor dermal tissues. Most commercially available ADM products are superficial cuts.

Other: Allograft Material ADM-S

Test Group:Acellular Dermal Matrix - Deep cut (ADM-D)

ACTIVE COMPARATOR

The use of a deep cut ADM for root coverage gingival plastic procedures.

Other: Allograft Material ADM-D

Interventions

Allograft Material ADM-SOTHER

A piece of the allograft material (ADM-D) will be hydrated per the manufacturers guidelines and adapted to the recipient area after reflection of a partial thickness flap. The flap will be coronally advanced to completely cover the graft material per standard care for this procedure.

Also known as: Acellular Dermal Matrix-superficial
Control Group: Acellular Dermal Matrix - Superficial cut (ADM-S)
Allograft Material ADM-DOTHER

A piece of the allograft material (ADM-S) will be hydrated per the manufacturers guidelines and adapted to the recipient area after reflection of a partial thickness flap. The flap will be coronally advanced to completely cover the graft material per standard care for this procedure.

Also known as: Acellular Dermal Matrix-deep
Test Group:Acellular Dermal Matrix - Deep cut (ADM-D)

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between age 18 and 89
  • Patients needing root coverage procedures for gingival recession in one or more teeth in the same arch bilaterally (split mouth)
  • Patients must be nonsmokers, former smokers, or current smokers who smoke \<10 cigarettes per day, by self-report.
  • Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.

You may not qualify if:

  • Patients who disclose that they will not be able to cooperate with the follow-up schedule.
  • Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
  • Pregnant women or women intending to become pregnant during study period.
  • Smokers who smoke \> 10 cigarettes per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Angela Palaiologou-Gallis, DDS, MS

    University of Texas Health Science Center San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a split-mouth design randomized, prospective trial designed to compare two standard of care techniques.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Program Director, Graduate Periodontics

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

October 3, 2023

Primary Completion

April 9, 2024

Study Completion

April 9, 2024

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

All collected de-identified Individual Participant data (IPD) that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
When summary data are published or otherwise made available

Locations

US(1)