A New Surgical-restorative Approach to Treat Gingival Recessions Associated With Non-carious Cervical Lesions (NCCL)

Gingival Recession Clinical Trial

Official title:

Evaluation of a New Surgical-restorative Approach for the Treatment of Gingival Recessions Associated With Non-carious Cervical Lesions: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817763
• Other study ID #: UEPJMF 4
• Status: Completed
• Phase: N/A
• First received: June 27, 2016
• Last updated: November 8, 2017
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2017
• 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 evaluate the clinical, aesthetic and patient-centered parameters of connective tissue graft associated or not with partial resin composite (RC) for the treatment of gingival recession with NCCL, performed before the surgical procedure.

Description:

This was a prospective, parallel and controlled clinical trial.

• Group CTG (control n = 20) - patients who received connective tissue graft to treat gingival recession associated with non-carious cervical lesion. Group CTG+RC (test n = 20) - patients who received connective tissue graft plus partial 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 Institute of Science and Technology (ICT), State University of São Paulo (UNESP). For those recessions allocated to CTG group, 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. Afterwards, a thin and small connective tissue graft was removed from the palatal site and sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft. For those recessions allocated to CTG+RC group, firstly a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter apically to the cemento-enamel junction estimation. In the following session the CTG+RC received the surgical procedure as described above where a thin and small connective tissue graft was removed from the palatal site and 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• 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
• Tooth Abrasion

Intervention

Procedure:
• Connective tissue graft (CTG)
Periodontal surgical technique to treat gingival recessions
• CTG plus resin composite restoration
Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss

Drug:
• sodium dipyrone
sodium dipyrone was recommended for all participants after the surgical procedures.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

References & Publications (3)

Santamaria MP, Ambrosano GM, Casati MZ, Nociti Júnior FH, Sallum AW, Sallum EA. Connective tissue graft plus resin-modified glass ionomer restoration for the treatment of gingival recession associated with non-carious cervical lesion: a randomized-controlled clinical trial. J Clin Periodontol. 2009 Sep;36(9):791-8. doi: 10.1111/j.1600-051X.2009.01441.x. Epub 2009 Jul 7. — View Citation

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. — 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	Percentage of Defect Coverage	Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.	6 months
Secondary	Modified Root Coverage Esthetic Score (MRES)	The MRES evaluated six variables: gingival margin (GM): 0 or 3 points; marginal tissue contour (MTC): 0 or 1 point; soft tissue texture (STT): 0 or 1 point; mucogingival junction alignment (MGJ): 0 or 1 point; gingival color (GC): 0 or 1 point; restoration/cervical lesion color (R/CLC): 0 points = color of restoration or uncovered cervical lesion does not match with tooth's color; 3 points = good color integration. Thus, 10 points was a perfect score.	6 months