GINGIVAL RECESSIONPhase 4NCT05782751
Growth Factor Enhanced Matrix With Subepithelial Connective Tissue Graft or Collagen Membrane in Treatment of Gingival Recession
A Phase 4 study testing GROUPI and GROUP II in people with GINGIVAL RECESSION, run by Tanta University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- GINGIVAL RECESSION
- What is being tested?
- GROUPI and GROUP II
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2019to 30 Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Malak Mohamed Shoukheba
Tanta, 020
Malak Yousef Mohamed Shoukheba
Tanta, 20
About this study
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
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.
Read the 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 .
- Conditions
- GINGIVAL RECESSION
- Being tested
- GROUPI, GROUP II
- Keywords
- Gingival recession, free subepithelial connective tissue graft, collagen membrane, growth factor enhanced matrix 21 s
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GROUPIProcedure or surgery
Also called free connective tissue graft, growth factors enhanced matrix 21s (GEM21s), coronally advanced flap
10 sites treated with Free connective tissue graft (FCTG) + growth factors enhanced matrix 21 s GEM 21S + coronally advanced flap (CAF)
GROUP IIProcedure or surgery
Also called collagen membrane, coronally advanced flap
10 sites treated withCollagen membrane + GEM 21S + coronally advanced flap (CAF)
| Study group | Role | What they receive |
|---|---|---|
| (groupI) | Experimental | 10 recession sites treated by (GEM 21s) ® with free connective tissue graft Receives: Procedure: GROUPI |
| (groupII) | Active comparator | 10 recession sites GEM 21s with collagen membrane Receives: Procedure: GROUP II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession width
the distance between the mesial and distal papillae along the CEJ measured at baseline , 1, 3, and 6 months
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 6 months
Secondary outcomes (4)
probing pocket depth
measured from gingival margin to the bottom of the pocket measured at baseline, 3, and 6 months
Measured: up to 6 months
clinical attachment level
measured from CEJ to the bottom of the pocket measured at baseline, 3, and 6 months
Measured: up to 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
Measured: up to 6 months
healing index
recorded at 1, 3 and 6 months postoperatively (Score 1: uneventful healing while score 3: poor wound healing
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Jan 2019
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GINGIVAL RECESSIONStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, malak mohamed shoukheba, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782751
- Sponsor's protocol ID
- 6
- Status last verified
- Mar 2023
- First submitted
- 27 Feb 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05782751
- Acronym / sponsor ID
- 6
- Conditions
- GINGIVAL RECESSION
- Keywords
- Gingival recession, free subepithelial connective tissue graft, collagen membrane, growth factor enhanced matrix 21 s
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (groupI) | Experimental | Procedure: GROUPI10 recession sites treated by (GEM 21s) ® with free connective tissue graft |
| (groupII) | Active comparator | Procedure: GROUP II10 recession sites GEM 21s with collagen membrane |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GROUPIAlso: free connective tissue graft, growth factors enhanced matrix 21s (GEM21s), coronally advanced flap10 sites treated with Free connective tissue graft (FCTG) + growth factors enhanced matrix 21 s GEM 21S + coronally advanced flap (CAF) | Procedure or surgery | (groupI) |
| GROUP IIAlso: collagen membrane, coronally advanced flap10 sites treated withCollagen membrane + GEM 21S + coronally advanced flap (CAF) | Procedure or surgery | (groupII) |
Primary outcome
Recession width
Time frame: up to 6 months
the distance between the mesial and distal papillae along the CEJ measured at baseline , 1, 3, and 6 months
recession depth
Time frame: up to 6 months
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
Time frame: up to 6 months
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)
Time frame: up to 6 months
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
Time frame: up to 6 months
from cone beam CT radiography measured at baseline, and 6 months postoperative
Percentage of root coverage
Time frame: up to 6 months
according to the following formula: (RD at baseline - RD at 6 months) / RD at baseline)x100 was calculated after 6 months
4 secondary outcomes
probing pocket depth
Time frame: up to 6 months
clinical attachment level
Time frame: up to 6 months
Digital measurements
Time frame: up to 6 months
healing index
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GROUPI and GROUP II in people with GINGIVAL RECESSION, run by Tanta University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession width (time frame: up to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.