Gingival RecessionNCT03341598
Two Surgical Approaches for Root Coverage of Teeth Presenting Gingival Recession and Non-carious Cervical Lesion
A study testing CAF, R and MC in people with Gingival Recession, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
The aim of the present study is to compare the use of the xenogeneic graft (MC) plus coronary advanced flap (CAF) and the coronary advanced flap alone, both associated with the partial restoration of composite resin in the treatment of gingival recessions associated with non-carious cervical lesion. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- CAF, R and MC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2017to 27 Jul 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- presenting Miller class I or II gingival recession in the maxillary canines or premolars associated with non-carious cervical lesion;
- teeth included in the study should present pulp vitality;
- patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤ 20%;
- patients older than 18 years old;
- probing depth ˂ 3 mm in the included teeth;
- patients who agreed to participate and signed an informed consent form
Who cannot join
- patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure
- patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure
- smokers or pregnant women
- patients who underwent periodontal surgery in the area of interest;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
São Paulo State University
São José dos Campos, São Paulo, 12245000
About this study
Official title: Comparison of Different Surgical Approaches for Root Coverage of Teeth Presenting With Gingival Recession Associated With Non-carious Cervical Lesion Partially Restored With Composite Resin. Randomized Controlled Clinical Trial
The aim of the present study is to compare the use of the xenogeneic graft (MC) plus coronary advanced flap (CAF) and the coronary advanced flap alone, both associated with the partial restoration of composite resin in the treatment of gingival recessions associated with non-carious cervical lesion.
Read the detailed description
This is a prospective, parallel and controlled clinical trial. The population evaluated in the study was selected at Institute of Science and Technology (ICT), São José dos Campos, College of Dentistry.
Sixty patients presenting gingival recession will be divided in 2 groups:
- Group 1 - Test: 30 gingival recessions associated with non-carious cervical lesions that will receive partial composite resin restoration and periodontal surgery for root coverage through a xenogenic collagen matrix graft (CAF + MC + R)
- Group 2 - control: 30 gingival recessions associated with non-carious cervical lesions that will receive partial composite resin restoration and periodontal surgery for root coverage (CAF + R) without graft.
The surgeries, as well as all postoperative follow-up, were performed at the dental clinic of ICT. Two horizontal incisions were made at right angles to the adjacent interdental papillae, without interfering with the gingival margins of neighboring teeth. Two oblique vertical incisions were extended beyond the mucogingival junction, and a trapezoidal mucoperiosteal flap was raised up to the mucogingival junction. After this point, a split-thickness flap was extended apically, releasing the tension and favoring coronal positioning of the flap.The exposed root surface was gently scaled and planed until it became smooth in the connective tissue graft (CTG) group. For those allocated to CTG plus composite resin (CR) group, a sterile rubber dam was placed to isolate the operative field and the non-carious cervical lesion restoration was performed with a nanocomposite resin (Filtek Supreme - 3M - St. Paul, Minnesota, USA), following the manufacturer's instructions. Afterward, the both groups received a thin and small connective tissue graft that was sutured over the root/restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
Clinical parameters were assessed at baseline and 3 and 6 months post-operatively.
Statistical Analysis The null hypothesis considered in the study was the absence of difference in the clinical parameters between the different groups. For data analysis, the statistical program was used (SigmaPlot). The demographic and clinical data were compared between the groups using Student's t-test. The data were first analyzed for homogeneity using the Shapiro-Wilk test, which indicated non-normal distribution. . Those presenting Shapiro-Wilk p values < 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney tests (for intergroup comparisons). Patients' esthetics and discomfort measures using a visual analog scale (VAS) were analyzed by T-tests. The frequency of sites that were scored as very good or excellent in each group by qualitative cosmetic evaluation (QCE) analysis, the frequency of complete root coverage, bleeding on probing (BOP), and the presence or absence of plaque at the site were compared using χ2 tests. Intergroup root esthetic scale (RES) comparisons were performed with a T-test. A significance level of 0.05 was adopted.
- Conditions
- Gingival Recession
- Being tested
- CAF, R, MC
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAFProcedure or surgery
Also called Periodontal plastic surgery
Periodontal surgical technique to treat gingival recessions.
RProcedure or surgery
Also called Composite resin restoration (Filtek Supreme - 3M)
Restorative procedure to treat tooth structure loss.
MCProcedure or surgery
Also called Xenogenous collagen matrix
Xenogenous graft placed in the surgical site.
| Study group | Role | What they receive |
|---|---|---|
| CAF+R | Active comparator | First of all, a sterile rubber dam will be placed to isolate the operative field and the non-carious cervical lesion restoration was performed with a nanocomposite resin (Filtek Supreme - 3M- St. Paul, Minnesota, USA), following the manufacturer's instructions. CAF treatment will be performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision will be made to unite the releasing incisions and the flap will be raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures will be placed to stabilize the flap in a coronal position 2 mm above the cementoenamel junction (CEJ), followed by interrupted sutures to close the releasing incisions. Receives: Procedure: CAF; Procedure: R |
| CAF+R+MC | Experimental | First of all, a sterile rubber dam will be placed to isolate the operative field and the non-carious cervical lesion restoration was performed with a nanocomposite resin (Filtek Supreme - 3M - St. Paul, Minnesota, USA), following the manufacturer's instructions. CAF treatment will be performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision will be made to unite the releasing incisions and the flap will be raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Additionally, this group will receive the xenogenous collagen matrix graft (Geistlich) on the recessed area before the sutures. Then, the flap will be coronally positioned and sutured to completely cover the graft. Receives: Procedure: CAF; Procedure: R; Procedure: MC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession reduction
Recession reduction from baseline measured in millimetres
Measured: 1 year
Secondary outcomes (1)
Root coverage esthetic score
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 posted14 Nov 2017
- Study start1 Feb 2017
- Primary completion4 May 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Mauro P Santamaria, PhD, Principal investigator, ICT-UNESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341598
- Sponsor's protocol ID
- UEPJMF 8
- Status last verified
- Aug 2020
- First submitted
- 11 May 2017
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zucchelli G, Gori G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Non-carious cervical lesions associated with gingival recessions: a decision-making process. J Periodontol. 2011 Dec;82(12):1713-24. doi: 10.1902/jop.2011.110080. Epub 2011 May 4.
PubMed 21542735Santamaria MP, Fernandes-Dias SB, Araujo CF, Lucas da Silva Neves F, Mathias IF, Rebelato Bechara Andere NM, Neves Jardini MA. 2-Year Assessment of Tissue Biostimulation With Low-Level Laser on the Outcomes of Connective Tissue Graft in the Treatment of Single Gingival Recession: A Randomized Clinical Trial. J Periodontol. 2017 Apr;88(4):320-328. doi: 10.1902/jop.2016.160391. Epub 2016 Nov 11.
PubMed 27834120Mathias-Santamaria IF, Silveira CA, Rossato A, Sampaio de Melo MA, Bresciani E, Santamaria MP. Single gingival recession associated with non-carious cervical lesion treated by partial restoration and coronally advanced flap with or without xenogenous collagen matrix: A randomized clinical trial evaluating the coverage procedures and restorative protocol. J Periodontol. 2022 Apr;93(4):504-514. doi: 10.1002/JPER.21-0358. Epub 2021 Aug 21.
PubMed 34310715
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Surgical Approaches for Root Coverage of Teeth Presenting With Gingival Recession Associated With Non-carious Cervical Lesion Partially Restored With Composite Resin. Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03341598
- Acronym / sponsor ID
- UEPJMF 8
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 14 Nov 2017 (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 aim of the present study is to compare the use of the xenogeneic graft (MC) plus coronary advanced flap (CAF) and the coronary advanced flap alone, both associated with the partial restoration of composite resin in the treatment of gingival recessions associated with non-carious cervical lesion.
Detailed description
This is a prospective, parallel and controlled clinical trial. The population evaluated in the study was selected at Institute of Science and Technology (ICT), São José dos Campos, College of Dentistry.
Sixty patients presenting gingival recession will be divided in 2 groups:
- Group 1 - Test: 30 gingival recessions associated with non-carious cervical lesions that will receive partial composite resin restoration and periodontal surgery for root coverage through a xenogenic collagen matrix graft (CAF + MC + R)
- Group 2 - control: 30 gingival recessions associated with non-carious cervical lesions that will receive partial composite resin restoration and periodontal surgery for root coverage (CAF + R) without graft.
The surgeries, as well as all postoperative follow-up, were performed at the dental clinic of ICT. Two horizontal incisions were made at right angles to the adjacent interdental papillae, without interfering with the gingival margins of neighboring teeth. Two oblique vertical incisions were extended beyond the mucogingival junction, and a trapezoidal mucoperiosteal flap was raised up to the mucogingival junction. After this point, a split-thickness flap was extended apically, releasing the tension and favoring coronal positioning of the flap.The exposed root surface was gently scaled and planed until it became smooth in the connective tissue graft (CTG) group. For those allocated to CTG plus composite resin (CR) group, a sterile rubber dam was placed to isolate the operative field and the non-carious cervical lesion restoration was performed with a nanocomposite resin (Filtek Supreme - 3M - St. Paul, Minnesota, USA), following the manufacturer's instructions. Afterward, the both groups received a thin and small connective tissue graft that was sutured over the root/restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.
Clinical parameters were assessed at baseline and 3 and 6 months post-operatively.
Statistical Analysis The null hypothesis considered in the study was the absence of difference in the clinical parameters between the different groups. For data analysis, the statistical program was used (SigmaPlot). The demographic and clinical data were compared between the groups using Student's t-test. The data were first analyzed for homogeneity using the Shapiro-Wilk test, which indicated non-normal distribution. . Those presenting Shapiro-Wilk p values < 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney tests (for intergroup comparisons). Patients' esthetics and discomfort measures using a visual analog scale (VAS) were analyzed by T-tests. The frequency of sites that were scored as very good or excellent in each group by qualitative cosmetic evaluation (QCE) analysis, the frequency of complete root coverage, bleeding on probing (BOP), and the presence or absence of plaque at the site were compared using χ2 tests. Intergroup root esthetic scale (RES) comparisons were performed with a T-test. A significance level of 0.05 was adopted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF+R | Active comparator | Procedure: CAF, Procedure: RFirst of all, a sterile rubber dam will be placed to isolate the operative field and the non-carious cervical lesion restoration was performed with a nanocomposite resin (Filtek Supreme - 3M- St. Paul, Minnesota, USA), following the manufacturer's instructions. CAF treatment will be performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision will be made to unite the releasing incisions and the flap will be raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Sling sutures will be placed to stabilize the flap in a coronal position 2 mm above the cementoenamel junction (CEJ), followed by interrupted sutures to close the releasing incisions. |
| CAF+R+MC | Experimental | Procedure: CAF, Procedure: R, Procedure: MCFirst of all, a sterile rubber dam will be placed to isolate the operative field and the non-carious cervical lesion restoration was performed with a nanocomposite resin (Filtek Supreme - 3M - St. Paul, Minnesota, USA), following the manufacturer's instructions. CAF treatment will be performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision will be made to unite the releasing incisions and the flap will be raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Additionally, this group will receive the xenogenous collagen matrix graft (Geistlich) on the recessed area before the sutures. Then, the flap will be coronally positioned and sutured to completely cover the graft. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- presenting Miller class I or II gingival recession in the maxillary canines or premolars associated with non-carious cervical lesion;
- teeth included in the study should present pulp vitality;
- patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤ 20%;
- patients older than 18 years old;
- probing depth ˂ 3 mm in the included teeth;
Key exclusion criteria (4 listed)
- patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure
- patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure
- smokers or pregnant women
- patients who underwent periodontal surgery in the area of interest;
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 |
|---|---|---|
| CAFAlso: Periodontal plastic surgeryPeriodontal surgical technique to treat gingival recessions. | Procedure or surgery | CAF+R, CAF+R+MC |
| RAlso: Composite resin restoration (Filtek Supreme - 3M)Restorative procedure to treat tooth structure loss. | Procedure or surgery | CAF+R, CAF+R+MC |
| MCAlso: Xenogenous collagen matrixXenogenous graft placed in the surgical site. | Procedure or surgery | CAF+R+MC |
Primary outcome
Recession reduction
Time frame: 1 year
Recession reduction from baseline measured in millimetres
1 secondary outcome
Root coverage esthetic score
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 2 Sep 2020.
- Background: PubMed 21542735Zucchelli G, Gori G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Non-carious cervical lesions associated with gingival recessions: a decision-making process. J Periodontol. 2011 Dec;82(12):1713-24. doi: 10.1902/jop.2011.110080. Epub 2011 May 4.
- Background: PubMed 27834120Santamaria MP, Fernandes-Dias SB, Araujo CF, Lucas da Silva Neves F, Mathias IF, Rebelato Bechara Andere NM, Neves Jardini MA. 2-Year Assessment of Tissue Biostimulation With Low-Level Laser on the Outcomes of Connective Tissue Graft in the Treatment of Single Gingival Recession: A Randomized Clinical Trial. J Periodontol. 2017 Apr;88(4):320-328. doi: 10.1902/jop.2016.160391. Epub 2016 Nov 11.
- Derived from this study: PubMed 34310715Mathias-Santamaria IF, Silveira CA, Rossato A, Sampaio de Melo MA, Bresciani E, Santamaria MP. Single gingival recession associated with non-carious cervical lesion treated by partial restoration and coronally advanced flap with or without xenogenous collagen matrix: A randomized clinical trial evaluating the coverage procedures and restorative protocol. J Periodontol. 2022 Apr;93(4):504-514. doi: 10.1002/JPER.21-0358. Epub 2021 Aug 21.
- 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.
Mauro P Santamaria, PhD principal investigator
ICT-UNESP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAF, R and MC in people with Gingival Recession, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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 6 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 2 Sep 2020. 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 Brazil. 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?
Recession reduction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03341598, which also lists 3 linked publications.
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 Sep 2020.