Back to resultsGrowth Factor Enhanced Matrix With Subepithelial Connective Tissue Graft or Collagen Membrane in Treatment of Gingival Recession
Primary Purpose
GINGIVAL RECESSION
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
GROUPI
GROUP II
Sponsored by
About this trial
This is an interventional treatment trial for GINGIVAL RECESSION focused on measuring Gingival recession, free subepithelial connective tissue graft, collagen membrane, growth factor enhanced matrix 21 s
Eligibility Criteria
Inclusion Criteria: lack of any related medical issues that contraindicate periodontal surgery, optimum adherence as confirmed by a positive attitude towards oral hygiene, and successfully showing up for treatment appointments. No history of any medications in the previous six months that may interfere with periodontal surgery Gingival thickness for the selected sites should be > 1mm (as measured 2mm apical to gingival margin), Clinical attachment level ≥ 4mm measured from cemento-enamel junction till the deepest probing depth. Exclusion Criteria: the presence of class V caries or restoration in the site to be treated, previous mucogingival surgery at the selected site. Teeth that are tilted, rotated, or have any occlusal abnormalities. Smokers and pregnant patients were excluded from the participation.
Sites / Locations
- Malak Mohamed Shoukheba
- Malak Yousef Mohamed Shoukheba
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
(groupI)
(groupII)
Arm Description
10 recession sites treated by (GEM 21s) ® with free connective tissue graft
10 recession sites GEM 21s with collagen membrane
Outcomes
Primary Outcome Measures
Recession width
the distance between the mesial and distal papillae along the CEJ measured at baseline , 1, 3, and 6 months
recession depth
The distance between the CEJ and the gingival margin at the midbuccal aspect of the involved tooth measured at baseline , 1, 3, and 6 months
Height of keratinized tissue
distance from the most apical point of the free gingival margin to the mucogingival junction mid-facially measured at baseline , 1, 3, and 6 months
Gingival thickness (Gingival biotype)
measured at mid-buccal area 2 mm apical to the free gingival margin measured at baseline, and 6 months postoperatively
radiographic measurements of facial bone level, thickness and density
from cone beam CT radiography measured at baseline, and 6 months postoperative
Percentage of root coverage
according to the following formula: (RD at baseline - RD at 6 months) / RD at baseline)x100 was calculated after 6 months
Secondary Outcome Measures
probing pocket depth
measured from gingival margin to the bottom of the pocket measured at baseline, 3, and 6 months
clinical attachment level
measured from CEJ to the bottom of the pocket measured at baseline, 3, and 6 months
Digital measurements
all recession areas were photographed The photos were taken by a digital camera at a fixed resolution (mega pixel) taken at baseline, 1,3,and 6 months postoperative
healing index
recorded at 1, 3 and 6 months postoperatively (Score 1: uneventful healing while score 3: poor wound healing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05782751
Brief Title
Growth Factor Enhanced Matrix With Subepithelial Connective Tissue Graft or Collagen Membrane in Treatment of Gingival Recession
Official Title
Growth Factor Enhanced Matrix Combined Either With Free Connective Tissue Graft or With Collagen Membrane in the Treatment of Miller Class II Gingival Recession
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The study aimed to compare, the effectiveness of Growth Factor Enhanced Matrix (GEM 21s) ® combined either with free connective tissue graft or collagen membrane in the treatment of Miller class II gingival recession.
Detailed Description
Materials and Methods: Twenty sites in 10 patients, with class II Miller gingival recession were allocated randomly to be treated by (GEM 21s) ® with free connective tissue graft (groupI) or GEM 21s with collagen membrane (groupII). Plaque index, bleeding on probing, recession width, recession depth, height of keratinized tissue and digital measurements were recorded at baseline, 1, 3 and 6-months'. Probing pocket depth, clinical attachment level, gingival thickness and Radiographic parameters were recorded at baseline and 6 months'. Root coverage percentage were recorded 6 months postoperative and wound healing index were recorded at 1,3 and 6-months' post-operative .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GINGIVAL RECESSION
Keywords
Gingival recession, free subepithelial connective tissue graft, collagen membrane, growth factor enhanced matrix 21 s
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
(groupI)
Arm Type
Experimental
Arm Description
10 recession sites treated by (GEM 21s) ® with free connective tissue graft
Arm Title
(groupII)
Arm Type
Active Comparator
Arm Description
10 recession sites GEM 21s with collagen membrane
Intervention Type
Procedure
Intervention Name(s)
GROUPI
Other Intervention Name(s)
free connective tissue graft, growth factors enhanced matrix 21s (GEM21s), coronally advanced flap
Intervention Description
10 sites treated with Free connective tissue graft (FCTG) + growth factors enhanced matrix 21 s GEM 21S + coronally advanced flap (CAF)
Intervention Type
Procedure
Intervention Name(s)
GROUP II
Other Intervention Name(s)
collagen membrane, coronally advanced flap
Intervention Description
10 sites treated withCollagen membrane + GEM 21S + coronally advanced flap (CAF)
Primary Outcome Measure Information:
Title
Recession width
Description
the distance between the mesial and distal papillae along the CEJ measured at baseline , 1, 3, and 6 months
Time Frame
up to 6 months
Title
recession depth
Description
The distance between the CEJ and the gingival margin at the midbuccal aspect of the involved tooth measured at baseline , 1, 3, and 6 months
Time Frame
up to 6 months
Title
Height of keratinized tissue
Description
distance from the most apical point of the free gingival margin to the mucogingival junction mid-facially measured at baseline , 1, 3, and 6 months
Time Frame
up to 6 months
Title
Gingival thickness (Gingival biotype)
Description
measured at mid-buccal area 2 mm apical to the free gingival margin measured at baseline, and 6 months postoperatively
Time Frame
up to 6 months
Title
radiographic measurements of facial bone level, thickness and density
Description
from cone beam CT radiography measured at baseline, and 6 months postoperative
Time Frame
up to 6 months
Title
Percentage of root coverage
Description
according to the following formula: (RD at baseline - RD at 6 months) / RD at baseline)x100 was calculated after 6 months
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
probing pocket depth
Description
measured from gingival margin to the bottom of the pocket measured at baseline, 3, and 6 months
Time Frame
up to 6 months
Title
clinical attachment level
Description
measured from CEJ to the bottom of the pocket measured at baseline, 3, and 6 months
Time Frame
up to 6 months
Title
Digital measurements
Description
all recession areas were photographed The photos were taken by a digital camera at a fixed resolution (mega pixel) taken at baseline, 1,3,and 6 months postoperative
Time Frame
up to 6 months
Title
healing index
Description
recorded at 1, 3 and 6 months postoperatively (Score 1: uneventful healing while score 3: poor wound healing
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lack of any related medical issues that contraindicate periodontal surgery,
optimum adherence as confirmed by a positive attitude towards oral hygiene, and successfully showing up for treatment appointments.
No history of any medications in the previous six months that may interfere with periodontal surgery Gingival thickness for the selected sites should be > 1mm (as measured 2mm apical to gingival margin),
Clinical attachment level ≥ 4mm measured from cemento-enamel junction till the deepest probing depth.
Exclusion Criteria:
the presence of class V caries or restoration in the site to be treated,
previous mucogingival surgery at the selected site.
Teeth that are tilted, rotated, or have any occlusal abnormalities.
Smokers and pregnant patients were excluded from the participation.
Facility Information:
Facility Name
Malak Mohamed Shoukheba
City
Tanta
ZIP/Postal Code
020
Country
Egypt
Facility Name
Malak Yousef Mohamed Shoukheba
City
Tanta
ZIP/Postal Code
20
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Growth Factor Enhanced Matrix With Subepithelial Connective Tissue Graft or Collagen Membrane in Treatment of Gingival Recession
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