NCT05688293

Brief Summary

Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (RT1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

January 6, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
2.1 years until next milestone

Study Start

First participant enrolled

February 5, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 11, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

January 6, 2023

Last Update Submit

February 8, 2025

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Gingival phenotype change

    determination of the change in gingival thickness in mm using periodontal probe

    at baseline 3,6 and 12 months

Secondary Outcomes (2)

  • Keratinized tissue width

    at baseline 3,6 and 12 months

  • Root coverage esthetic score (RES)

    at baseline 3,6 and 12 months

Study Arms (3)

Connective tissue graft

ACTIVE COMPARATOR

Patients will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique

Procedure: Connective tissue graft

Free gingival Graft

ACTIVE COMPARATOR

Patients will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft

Procedure: Free gingival graft

Non surgical procedure

ACTIVE COMPARATOR

Patients will receive non-surgical periodontal treatment only

Procedure: Non surgical

Interventions

Connective tissue graftPROCEDURE

non-surgical periodontal treatment and connective tissue graft

Connective tissue graft
Free gingival graftPROCEDURE

will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft

Free gingival Graft
Non surgicalPROCEDURE

non-surgical periodontal treatment only

Non surgical procedure

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Medically free patients (American Society of Anesthesiologists I; ASA I)
  • Patients diagnosed with recession (RT1)
  • Fair oral hygiene
  • Patient accepting to provides an informed consent and the follow-up

You may not qualify if:

  • Carious teeth and teeth with periapical infection.
  • Patients diagnosed with periodontitis
  • Smokers
  • Pregnant and lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of oral and dental medicine, Misr international university

Cairo, 12345, Egypt

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Zainab Hafez, Lecturer

    Lecturer, faculty of oral and dental medicine misr international university

    PRINCIPAL INVESTIGATOR

  • Shahinaz Al ashiry, Asso. Prof

    Associate professor, faculty of oral and dental medicine misr international university

    STUDY DIRECTOR

  • Yahia Amer, Lecturer

    Lecturer, faculty of oral and dental medicine misr international universit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zainab Hafez, Lecturer

CONTACT

+01221334637zeinab.hafez@miuegypt.edu.eg

Shahinaz Al ashiry, Asso. Prof

CONTACT

shahinaz.elashiry@miuegypt.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
the patient won't know the type of the procedures done to him The outcome assessor won't know which group he the is assessing it's results
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three parallel groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2023

First Posted

January 18, 2023

Study Start

February 5, 2025

Primary Completion

January 20, 2026

Study Completion

March 1, 2026

Last Updated

February 11, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)