Gingival RecessionPhase 2NCT02980055
Comparison of Root Coverage of Gingival Recessions
A Phase 2 study testing collagen matrix and connective tissue graft in people with Gingival Recession, run by Universidade Federal do Rio Grande do Norte.
Trial summary
The purpose of this study is to analyze the percentage of root coverage in Miller class I and II gingival recessions using connective tissue graft and collagen matrix with a two years follow-up. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- collagen matrix and connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Feb 2019
- Phase
- Phase 2
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Gingival recessions of class I or II types according to Miller (1985), in contralateral, superior or inferior premolars and / or canines;
- Fine periodontal biotype characterized by the transparency of the North Carolina probe when introduced into the periodontal sulcus (KAN et al., 2003);
- The teeth with gingival recession should not be restored in their cervical portion;
- Periodontal health characterized by absence of bleeding at probing, depth of probing less than 3 mm;
- Visible Plaque Index and Gingival Bleeding Index less than or equal to 30%.
Who cannot join
- Orthodontic appliances;
- Fixed or removable prostheses involving the premolar teeth with gingival recession;
- Being a smoker;
- Pregnancy or lactation;
- Systemic diseases that may interfere with healing or periodontal health (diabetes, leukemia, hypertension, among others).
Trial locations and contacts
No sites are listed yet.
Samuel B Borges, student contact
About this study
Official title: Comparison of Root Coverage of Gingival Recessions Using Connective Tissue Graft and Collagen Matrix
The purpose of this study is to analyze the percentage of root coverage in Miller class I and II gingival recessions using connective tissue graft and collagen matrix with a two years follow-up.
Read the detailed description
A sample calculation using a mean of 2.92 mm of the quantity of keratinized mucosa obtained after six months in the most recent study (McGUIRE; SCHEYER, 2014) using the same collagen matrix with a standard deviation of ± 0.88 mm, a difference of 0.4 mm being chosen as statistically significant. In addition, a 95% bilateral confidence interval and 80% power were used. A sample of 38 individuals per group was obtained. In addition, a 20% loss is expected during follow-up, a total of 46 individuals should be evaluated.
Periapical radiographic examinations should be performed before the collection of data to confirm the absence of bone loss. The following clinical parameters should be evaluated in both test and control groups: visible plaque index, gingival bleeding index, gingival recession, keratinized mucosa width and thickness, probing depth, bleeding on probing and periodontal biotype for each teeth with a North Carolina periodontal probe. The periodontal biotype for each teeth should be rated as thin or thick, according to probe transparency during probing depth. For statistical purposes, percentages of faces with gingival recession should be calculated. These parameters should be evaluated at baseline and at one, three and six months, one and two years post-therapy.
Clinical parameters should be collected by two operators, calibrated by the Kappa test for the keratinized mucosa width and thickness, periodontal biotype, probing depth and gingival recession.
After the inclusion of the patients, anamnesis and initial examination were performed. The subjects should be divided randomly, using a simple draw, in the following two groups: test - (collagen matrix) and control - (connective tissue graft) placebo associated with basic periodontal therapy). The data should be analyzed using descriptive and inferential statistics, with parametric tests, through the software package Social Sciences (SPSS), version 17.0 (free version).
- Conditions
- Gingival Recession
- Being tested
- collagen matrix, connective tissue graft
- Keywords
- connective tissue graft, transplantation, collagen, autologous, gingiva
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagen matrixProcedure or surgery
Also called xenogeneic collagen matrix
Surgical procedure for root coverage using collagen matrix
connective tissue graftProcedure or surgery
Also called autologous
Surgical procedure for root coverage using connective tissue graft
| Study group | Role | What they receive |
|---|---|---|
| Test: collagen matrix | Experimental | Root coverage using collagen matrix Receives: Procedure: collagen matrix |
| Control: connective tissue graft | Active comparator | Root coverage using connective tissue graft Receives: Procedure: connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival recession
Measured: baseline
gingival recession
Measured: three months
gingival recession
Measured: six months
gingival recession
Measured: twelve months
gingival recession
Measured: eighteen months
gingival recession
Measured: twenty-four months
Secondary outcomes (1)
Width of keratinized mucosa
Measured: baseline and three, six, twelve, eighteen and twenty-four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startFeb 2017
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2019 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karyna de Melo Menezes, Universidade Federal do Rio Grande do Norte
- Investigators
- Karyna M Menezes, Master, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980055
- Sponsor's protocol ID
- UFRN-3
- Status last verified
- Nov 2016
- First submitted
- 28 Nov 2016
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Root Coverage of Gingival Recessions Using Connective Tissue Graft and Collagen Matrix
- ClinicalTrials.gov ID
- NCT02980055
- Acronym / sponsor ID
- UFRN-3
- Conditions
- Gingival Recession
- Keywords
- connective tissue graft, transplantation, collagen, autologous, gingiva
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 2 Dec 2016 (estimated)
- 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 purpose of this study is to analyze the percentage of root coverage in Miller class I and II gingival recessions using connective tissue graft and collagen matrix with a two years follow-up.
Detailed description
A sample calculation using a mean of 2.92 mm of the quantity of keratinized mucosa obtained after six months in the most recent study (McGUIRE; SCHEYER, 2014) using the same collagen matrix with a standard deviation of ± 0.88 mm, a difference of 0.4 mm being chosen as statistically significant. In addition, a 95% bilateral confidence interval and 80% power were used. A sample of 38 individuals per group was obtained. In addition, a 20% loss is expected during follow-up, a total of 46 individuals should be evaluated.
Periapical radiographic examinations should be performed before the collection of data to confirm the absence of bone loss. The following clinical parameters should be evaluated in both test and control groups: visible plaque index, gingival bleeding index, gingival recession, keratinized mucosa width and thickness, probing depth, bleeding on probing and periodontal biotype for each teeth with a North Carolina periodontal probe. The periodontal biotype for each teeth should be rated as thin or thick, according to probe transparency during probing depth. For statistical purposes, percentages of faces with gingival recession should be calculated. These parameters should be evaluated at baseline and at one, three and six months, one and two years post-therapy.
Clinical parameters should be collected by two operators, calibrated by the Kappa test for the keratinized mucosa width and thickness, periodontal biotype, probing depth and gingival recession.
After the inclusion of the patients, anamnesis and initial examination were performed. The subjects should be divided randomly, using a simple draw, in the following two groups: test - (collagen matrix) and control - (connective tissue graft) placebo associated with basic periodontal therapy). The data should be analyzed using descriptive and inferential statistics, with parametric tests, through the software package Social Sciences (SPSS), version 17.0 (free version).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test: collagen matrix | Experimental | Procedure: collagen matrixRoot coverage using collagen matrix |
| Control: connective tissue graft | Active comparator | Procedure: connective tissue graftRoot coverage using connective tissue graft |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gingival recessions of class I or II types according to Miller (1985), in contralateral, superior or inferior premolars and / or canines;
- Fine periodontal biotype characterized by the transparency of the North Carolina probe when introduced into the periodontal sulcus (KAN et al., 2003);
- The teeth with gingival recession should not be restored in their cervical portion;
- Periodontal health characterized by absence of bleeding at probing, depth of probing less than 3 mm;
- Visible Plaque Index and Gingival Bleeding Index less than or equal to 30%.
Key exclusion criteria (5 listed)
- Orthodontic appliances;
- Fixed or removable prostheses involving the premolar teeth with gingival recession;
- Being a smoker;
- Pregnancy or lactation;
- Systemic diseases that may interfere with healing or periodontal health (diabetes, leukemia, hypertension, among others).
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 |
|---|---|---|
| collagen matrixAlso: xenogeneic collagen matrixSurgical procedure for root coverage using collagen matrix | Procedure or surgery | Test: collagen matrix |
| connective tissue graftAlso: autologousSurgical procedure for root coverage using connective tissue graft | Procedure or surgery | Control: connective tissue graft |
Primary outcome
gingival recession
Time frame: baseline
gingival recession
Time frame: three months
gingival recession
Time frame: six months
gingival recession
Time frame: twelve months
gingival recession
Time frame: eighteen months
gingival recession
Time frame: twenty-four months
1 secondary outcome
Width of keratinized mucosa
Time frame: baseline and three, six, twelve, eighteen and twenty-four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- Individual participant dataSharing planned: No
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Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
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i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
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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.
Samuel B Borges, student contact
Karyna M Menezes, Master principal investigator
Universidade Federal do Rio Grande do Norte
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing collagen matrix and connective tissue graft in people with Gingival Recession, run by Universidade Federal do Rio Grande do Norte.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno CV Gurgel, Doctor (+558432154107, bcgurgel@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gingival recession (time frame: baseline). 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 2 Dec 2016.