Gingival RecessionNCT04966208
Gingival Recession Treatment Using Two Different Surgical Techniques
A study testing xenogeneic collagen matrix in people with Gingival Recession and Root Planing, run by Assiut University at 1 site in Egypt.
Trial summary
Coronally the advanced flap is considered a predictable treatment of gingival recession but in certain situations, it needs a filler like subperiosteal connective tissue graft (CTG) which is considered as the gold standard treatment approach. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Root Planing
- What is being tested?
- xenogeneic collagen matrix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 15 Jun 2021
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -The selected patients for this study are non-smokers, aged 18-60 years with multiple gingival recession (Miller class 1, or 2.) for more than two adjacent affected teeth with plaque score less than 25%
Who cannot join
- -Patients with systemic complications, psychological problems, parafunctional habits, or patients presented with Mal-posed teeth, hypermobile teeth, teeth with Miller class 3 gingival recession were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Root Coverage Using Tunneling Technique of Xenogenic Collagen Matrix vs. Autologous Connective Tissue as a Treatment of Miller Class Two Gingival Recession (RCT Study)
Coronally the advanced flap is considered a predictable treatment of gingival recession but in certain situations, it needs a filler like subperiosteal connective tissue graft (CTG) which is considered as the gold standard treatment approach.
This randomized controlled trial compares the clinical benefits and effectiveness of a xenogenic collagen matrix (mucoderm, botiss, dental, Berlin, Germany) as a filler to the subperiosteal connective tissue graft (CTG).
- Conditions
- Gingival Recession, Root Planing
- Being tested
- xenogeneic collagen matrix
- Keywords
- root coverage, mucoderm, connective tissue, grafts
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xenogeneic collagen matrixProcedure or surgery
xenogeneic collagen matrix called mucoderm used for root coverage for treatment of gingival recession instead of harvesting from the patients connective tissue
| Study group | Role | What they receive |
|---|---|---|
| root coverage surgeries using autologous connective tissue for treatment of gingival recession | Active comparator | root coverage surgeries using tunneling technique of autologous connective tissue as a treatment of Miller class two gingival recession Receives: Procedure: xenogeneic collagen matrix |
| root coverage surgeries using xenogenic collagen matrix for treatment of gingival recession | Experimental | root coverage surgeries using tunneling technique of mucodrm membrane ; xenogeneic collagen matrix as a treatment of Miller class two gingival recession Receives: Procedure: xenogeneic collagen matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
The zone of keratinized gingiva
The distance from the tip of the papilla to the mucogingival junction minus the probing depth measured in mm using graduated periodontal probe.
Measured: 6 months after the surgery
Secondary outcomes (4)
Periodontal probing depth
measured from the gingival margin to the depth of the gingival sulcus in six sites per tooth and measured in mm.
Measured: 6 months after the surgery
Clinical attachment loss
measured from the cementoenamel junction to the depth of the sulcus in six sites per tooth and measured in mm.
Measured: 6 months after the surgery
Gingival recession
The depth measured from the gingival margin to the cementoenamel junction in mm.
Measured: 6 months after the surgery
Patient satisfaction of the esthetics
measured using the visual analog scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Sep 2020
- Primary completion1 Mar 2021
- Study completion15 Jun 2021
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 Assiut 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mortada, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966208
- Sponsor's protocol ID
- FDBSUREC/08042021/FA
- Status last verified
- Jul 2021
- First submitted
- 21 Jun 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Root Coverage Using Tunneling Technique of Xenogenic Collagen Matrix vs. Autologous Connective Tissue as a Treatment of Miller Class Two Gingival Recession (RCT Study)
- ClinicalTrials.gov ID
- NCT04966208
- Acronym / sponsor ID
- FDBSUREC/08042021/FA
- Conditions
- Gingival Recession, Root Planing
- Keywords
- root coverage, mucoderm, connective tissue, grafts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 19 Jul 2021 (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.
Coronally the advanced flap is considered a predictable treatment of gingival recession but in certain situations, it needs a filler like subperiosteal connective tissue graft (CTG) which is considered as the gold standard treatment approach.
This randomized controlled trial compares the clinical benefits and effectiveness of a xenogenic collagen matrix (mucoderm, botiss, dental, Berlin, Germany) as a filler to the subperiosteal connective tissue graft (CTG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| root coverage surgeries using autologous connective tissue for treatment of gingival recession | Active comparator | Procedure: xenogeneic collagen matrixroot coverage surgeries using tunneling technique of autologous connective tissue as a treatment of Miller class two gingival recession |
| root coverage surgeries using xenogenic collagen matrix for treatment of gingival recession | Experimental | Procedure: xenogeneic collagen matrixroot coverage surgeries using tunneling technique of mucodrm membrane ; xenogeneic collagen matrix as a treatment of Miller class two gingival recession |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -The selected patients for this study are non-smokers, aged 18-60 years with multiple gingival recession (Miller class 1, or 2.) for more than two adjacent affected teeth with plaque score less than 25%
Key exclusion criteria (1 listed)
- -Patients with systemic complications, psychological problems, parafunctional habits, or patients presented with Mal-posed teeth, hypermobile teeth, teeth with Miller class 3 gingival recession were excluded from this study.
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 |
|---|---|---|
| xenogeneic collagen matrixxenogeneic collagen matrix called mucoderm used for root coverage for treatment of gingival recession instead of harvesting from the patients connective tissue | Procedure or surgery | root coverage surgeries using autologous connective tissue for treatment of gingival recession, root coverage surgeries using xenogenic collagen matrix for treatment of gingival recession |
Primary outcome
The zone of keratinized gingiva
Time frame: 6 months after the surgery
The distance from the tip of the papilla to the mucogingival junction minus the probing depth measured in mm using graduated periodontal probe.
4 secondary outcomes
Periodontal probing depth
Time frame: 6 months after the surgery
Clinical attachment loss
Time frame: 6 months after the surgery
Gingival recession
Time frame: 6 months after the surgery
Patient satisfaction of the esthetics
Time frame: 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 19 Jul 2021.
- Individual participant dataSharing planned: No
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
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Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
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Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
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Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.
Gingival Recession
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xenogeneic collagen matrix in people with Gingival Recession and Root Planing, run by Assiut University at 1 site 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 1 inclusion and 1 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 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
The zone of keratinized gingiva (time frame: 6 months after the surgery). 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 19 Jul 2021.