Two Surgical Approaches for Root Coverage of Teeth Presenting Gingival Recession and Non-carious Cervical Lesion

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341598
• Other study ID #: UEPJMF 8
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: July 27, 2018

Study information

• Verified date: August 2020
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 27, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• CAF
Periodontal surgical technique to treat gingival recessions.
• R
Restorative procedure to treat tooth structure loss.
• MC
Xenogenous graft placed in the surgical site.

Locations

Country	Name	City	State
Brazil	São Paulo State University	São José dos Campos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Santamaria MP, Fernandes-Dias SB, Araújo 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recession reduction	Recession reduction from baseline measured in millimetres	1 year
Secondary	Root coverage esthetic score		6 months