NCT05782751

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

January 1, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

3.7 years

First QC Date

February 27, 2023

Last Update Submit

March 21, 2023

Conditions

GINGIVAL RECESSION

Keywords

Gingival recessionfree subepithelial connective tissue graftcollagen membranegrowth factor enhanced matrix 21 s

Outcome Measures

Primary Outcomes (6)

  • Recession width

    the distance between the mesial and distal papillae along the CEJ measured at baseline , 1, 3, and 6 months

    up to 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

    up to 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

    up to 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

    up to 6 months

  • radiographic measurements of facial bone level, thickness and density

    from cone beam CT radiography measured at baseline, and 6 months postoperative

    up to 6 months

  • 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

    up to 6 months

Secondary Outcomes (4)

  • probing pocket depth

    up to 6 months

  • clinical attachment level

    up to 6 months

  • Digital measurements

    up to 6 months

  • healing index

    up to 6 months

Study Arms (2)

(groupI)

EXPERIMENTAL

10 recession sites treated by (GEM 21s) ® with free connective tissue graft

Procedure: GROUPI

(groupII)

ACTIVE COMPARATOR

10 recession sites GEM 21s with collagen membrane

Procedure: GROUP II

Interventions

GROUPIPROCEDURE

10 sites treated with Free connective tissue graft (FCTG) + growth factors enhanced matrix 21 s GEM 21S + coronally advanced flap (CAF)

Also known as: free connective tissue graft, growth factors enhanced matrix 21s (GEM21s), coronally advanced flap
(groupI)
GROUP IIPROCEDURE

10 sites treated withCollagen membrane + GEM 21S + coronally advanced flap (CAF)

Also known as: collagen membrane, coronally advanced flap
(groupII)

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Malak Mohamed Shoukheba

Tanta, 020, Egypt

Location

Malak Yousef Mohamed Shoukheba

Tanta, 20, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of oral medicine, oral periodontology, oral diagnosis and diagnosis

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 24, 2023

Study Start

January 1, 2019

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

EG(2)