NCT04849663

Brief Summary

Compare between Buccal fat pad and subepithelial connective tissue graft in treatment of localized recession. Primary objective: to evaluate root coverage in terms of gingival thickness and esthetic. Secondary objective: to evaluate patient satisfaction and postoperative pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2018

Typical duration for early_phase_1

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

June 24, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
Last Updated

February 14, 2022

Status Verified

January 1, 2022

Enrollment Period

2.6 years

First QC Date

March 31, 2021

Last Update Submit

January 30, 2022

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • evaluation of root coverage esthetic score

    evaluation of root gingival coverage after modified Coronally advanced flap the scale is from 1-4 ... based on degree of coverage the score will be given 1=1005, 2=75%, 3=50%, 4=25%

    6 months

Study Arms (2)

study group

EXPERIMENTAL

Use of free fat graft to cover exposed root

Biological: free fat graft

control group

ACTIVE COMPARATOR

use of sub epithelial connective tissue graft to cover exposed root

Biological: subepithelial graft

Interventions

free fat graftBIOLOGICAL

fat harvested from patient will be used to cover exposed root

study group
subepithelial graftBIOLOGICAL

subepitheial graft harvested from palate

control group

Eligibility Criteria

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

You may qualify if:

  • Patients should be above 18 years.
  • Patient included in the study will be with Miller class II recession defect.
  • Patient having at least 1 mm of residual keratinized tissue.

You may not qualify if:

  • Patient with Systemic Problem affecting the results of periodontal Therapy.
  • Patients having allergy to drugs.
  • Pregnant women.
  • Patients with any smoking habits.
  • Patients having bleeding problems or on anticoagulant therapy.
  • Patients having caries or restorations in relation to the treated site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, 11757, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • shehad wael

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 19, 2021

Study Start

June 24, 2018

Primary Completion

January 24, 2021

Study Completion

January 24, 2021

Last Updated

February 14, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)