Gingival RecessionNCT02423473
Composite Resin Plus Connective Tissue Graft.
A study testing Connective tissue graft and Composite resin restoration (Filtek Supreme - 3M) in people with Gingival Recession, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial summary
The aim of the present study is to evaluate the clinical, aesthetic and patient-centered parameters of connective tissue graft associated or not with composite resin for the treatment of gingival recession. 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?
- Connective tissue graft and Composite resin restoration (Filtek Supreme - 3M)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Feb 2015
- 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; and
About this study
Official title: Composite Resin Plus Connective Tissue Graft to Treat Gingival Recession Associated With Non-carious Cervical Lesion. Randomized Clinical Trial
The aim of the present study is to evaluate the clinical, aesthetic and patient-centered parameters of connective tissue graft associated or not with composite resin for the treatment of gingival recession.
Read the detailed description
This was a prospective, parallel and controlled clinical trial.
Group CTG (n = 18) - patients who received connective tissue graft to treat gingival recession associated with non-carious cervical lesion. Group CTG+RC (n = 18) - patients who received connective tissue graft plus resin composite restoration to treat gingival recession associated with non-carious cervical lesion.
The surgeries, as well as all postoperative follow-up, were performed at the dental clinic of ICT- UNESP. 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 CTG group. For those allocated to CTG+RC 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 ESPE - St. Paul, MN, 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 VAS were analyzed by T-tests. The frequency of sites that were scored as very good or excellent in each group by QCE analysis, the frequency of complete root coverage, BOP, and the presence or absence of plaque at the site were compared using χ2 tests. Intergroup RES comparisons were performed with a T-test. A significance level of 0.05 was adopted.
- Conditions
- Gingival Recession
- Being tested
- Connective tissue graft, Composite resin restoration (Filtek Supreme - 3M)
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graftProcedure or surgery
Also called Periodontal plastic surgery
Periodontal surgical technique to treat gingival recessions
Composite resin restoration (Filtek Supreme - 3M)Procedure or surgery
Also called Non-carious cervical lesion restoration
Restorative procedure do treat tooth structure loss
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue graft (CTG) | Active comparator | After local anesthesia, the surgical procedure performed was the trapezoidal-type of CAF (de Sanctis \& Zucchelli, 2007). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft. Receives: Procedure: Connective tissue graft |
| Connective tissue graft plus composite resin restoration. | Experimental | After local anesthesia, the surgical procedure performed was the trapezoidal-type of CAF (de Sanctis \& Zucchelli, 2007). After the flap was raised, 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 ESPE - St. Paul, MN, USA), following the manufacturer's instructions. Afterward, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft. Receives: Procedure: Connective tissue graft; Procedure: Composite resin restoration (Filtek Supreme - 3M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of defect coverage
Measured: 1 year
Secondary outcomes (1)
Root coverage esthetic score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startAug 2011
- Primary completionOct 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 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
- NCT02423473
- Sponsor's protocol ID
- 071/2010
- Status last verified
- Apr 2015
- First submitted
- 3 Apr 2015
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Santamaria MP, da Silva Feitosa D, Casati MZ, Nociti FH Jr, Sallum AW, Sallum EA. Randomized controlled clinical trial evaluating connective tissue graft plus resin-modified glass ionomer restoration for the treatment of gingival recession associated with non-carious cervical lesion: 2-year follow-up. J Periodontol. 2013 Sep;84(9):e1-8. doi: 10.1902/jop.2013.120447. Epub 2013 Jan 31.
PubMed 23368948
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Composite Resin Plus Connective Tissue Graft to Treat Gingival Recession Associated With Non-carious Cervical Lesion. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02423473
- Acronym / sponsor ID
- 071/2010
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Apr 2015 (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 aim of the present study is to evaluate the clinical, aesthetic and patient-centered parameters of connective tissue graft associated or not with composite resin for the treatment of gingival recession.
Detailed description
This was a prospective, parallel and controlled clinical trial.
Group CTG (n = 18) - patients who received connective tissue graft to treat gingival recession associated with non-carious cervical lesion. Group CTG+RC (n = 18) - patients who received connective tissue graft plus resin composite restoration to treat gingival recession associated with non-carious cervical lesion.
The surgeries, as well as all postoperative follow-up, were performed at the dental clinic of ICT- UNESP. 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 CTG group. For those allocated to CTG+RC 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 ESPE - St. Paul, MN, 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 VAS were analyzed by T-tests. The frequency of sites that were scored as very good or excellent in each group by QCE analysis, the frequency of complete root coverage, BOP, and the presence or absence of plaque at the site were compared using χ2 tests. Intergroup 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
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective tissue graft (CTG) | Active comparator | Procedure: Connective tissue graftAfter local anesthesia, the surgical procedure performed was the trapezoidal-type of CAF (de Sanctis \& Zucchelli, 2007). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft. |
| Connective tissue graft plus composite resin restoration. | Experimental | Procedure: Connective tissue graft, Procedure: Composite resin restoration (Filtek Supreme - 3M)After local anesthesia, the surgical procedure performed was the trapezoidal-type of CAF (de Sanctis \& Zucchelli, 2007). After the flap was raised, 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 ESPE - St. Paul, MN, USA), following the manufacturer's instructions. Afterward, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was 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; and
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 |
|---|---|---|
| Connective tissue graftAlso: Periodontal plastic surgeryPeriodontal surgical technique to treat gingival recessions | Procedure or surgery | Connective tissue graft (CTG), Connective tissue graft plus composite resin restoration. |
| Composite resin restoration (Filtek Supreme - 3M)Also: Non-carious cervical lesion restorationRestorative procedure do treat tooth structure loss | Procedure or surgery | Connective tissue graft plus composite resin restoration. |
Primary outcome
Percentage of defect coverage
Time frame: 1 year
1 secondary outcome
Root coverage esthetic score
Time frame: 1 year
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 23 Apr 2015.
- Background: PubMed 23368948Santamaria MP, da Silva Feitosa D, Casati MZ, Nociti FH Jr, Sallum AW, Sallum EA. Randomized controlled clinical trial evaluating connective tissue graft plus resin-modified glass ionomer restoration for the treatment of gingival recession associated with non-carious cervical lesion: 2-year follow-up. J Periodontol. 2013 Sep;84(9):e1-8. doi: 10.1902/jop.2013.120447. Epub 2013 Jan 31.
Related trials for Gingival Recession
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
Not yet recruiting
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
Recruiting
Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Gingival Recession, Mucogingival Surgery
Recruiting
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.
Mauro P Santamaria, PhD principal investigator
ICT-UNESP
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue graft and Composite resin restoration (Filtek Supreme - 3M) in people with Gingival Recession, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
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 23 Apr 2015. 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.
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?
Percentage of defect coverage (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 NCT02423473, which also lists 1 linked publication.
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 23 Apr 2015.