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Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries

Primary Purpose

Gingival Recession

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Connective tissue graft
Free gingival graft
Non surgical
Sponsored by
Misr International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: Carious teeth and teeth with periapical infection. Patients diagnosed with periodontitis Smokers Pregnant and lactating females

Sites / Locations

  • Faculty of oral and dental medicine, Misr international universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Connective tissue graft

Free gingival Graft

Non surgical procedure

Arm Description

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

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

Patients will receive non-surgical periodontal treatment only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Keratinized tissue width
determination of Keratinized tissue width in mm using periodontal probe
Root coverage esthetic score (RES)
It is a scoring system to assess the level of gingival margin (GM),marginal tissue contour (MTC),Soft tissue texture, Mucogingival alignment (MGJ),Gingival color The score is 0,1 and 3 where 0 is the minimum and 3 is the maximum

Full Information

First Posted
January 6, 2023
Last Updated
January 14, 2023
Sponsor
Misr International University
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1. Study Identification

Unique Protocol Identification Number
NCT05688293
Brief Title
Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries
Official Title
Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
January 20, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Misr International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. They will be randomly allocated to three equal groups. Group A (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, Group B (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group C (control group, n=10) will receive non-surgical periodontal treatment only. After 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). This parameter will be recorded at baseline, 3, 6 and 12 months. The 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be masked. Follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three parallel groups
Masking
ParticipantOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Connective tissue graft
Arm Type
Active Comparator
Arm Description
Patients will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique
Arm Title
Free gingival Graft
Arm Type
Active Comparator
Arm Description
Patients will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft
Arm Title
Non surgical procedure
Arm Type
Active Comparator
Arm Description
Patients will receive non-surgical periodontal treatment only
Intervention Type
Procedure
Intervention Name(s)
Connective tissue graft
Intervention Description
non-surgical periodontal treatment and connective tissue graft
Intervention Type
Procedure
Intervention Name(s)
Free gingival graft
Intervention Description
will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft
Intervention Type
Procedure
Intervention Name(s)
Non surgical
Intervention Description
non-surgical periodontal treatment only
Primary Outcome Measure Information:
Title
Gingival phenotype change
Description
determination of the change in gingival thickness in mm using periodontal probe
Time Frame
at baseline 3,6 and 12 months
Secondary Outcome Measure Information:
Title
Keratinized tissue width
Description
determination of Keratinized tissue width in mm using periodontal probe
Time Frame
at baseline 3,6 and 12 months
Title
Root coverage esthetic score (RES)
Description
It is a scoring system to assess the level of gingival margin (GM),marginal tissue contour (MTC),Soft tissue texture, Mucogingival alignment (MGJ),Gingival color The score is 0,1 and 3 where 0 is the minimum and 3 is the maximum
Time Frame
at baseline 3,6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Carious teeth and teeth with periapical infection. Patients diagnosed with periodontitis Smokers Pregnant and lactating females
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zainab Hafez, Lecturer
Phone
+01221334637
Email
zeinab.hafez@miuegypt.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Shahinaz Al ashiry, Asso. Prof
Email
shahinaz.elashiry@miuegypt.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zainab Hafez, Lecturer
Organizational Affiliation
Lecturer, faculty of oral and dental medicine misr international university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shahinaz Al ashiry, Asso. Prof
Organizational Affiliation
Associate professor, faculty of oral and dental medicine misr international university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yahia Amer, Lecturer
Organizational Affiliation
Lecturer, faculty of oral and dental medicine misr international universit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of oral and dental medicine, Misr international university
City
Cairo
ZIP/Postal Code
12345
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zainab Hafez, Lecturer
Email
zeinab.hafez@miuegypt.edu.eg
First Name & Middle Initial & Last Name & Degree
Yahia amer, Lecturer
Email
yahia.hassan@miuegypt.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries

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