Clinical trial NCT02817763: A New Surgical-restorative Approach to Treat Gingival Recessions Associated With Non-carious Cervical Lesions (NCCL)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Tooth Abrasion
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Defect Coverage
timeFrame: 6 months
Secondary outcomes:
measure: Modified Root Coverage Esthetic Score (MRES)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: ICT-UNESP
name: Mauro P Santamaria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Santamaria MP, Ambrosano GM, Casati MZ, Nociti Junior 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.
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.
citation: Santamaria MP, Silveira CA, Mathias IF, Neves FLDS, Dos Santos LM, Jardini MAN, Tatakis DN, Sallum EA, Bresciani E. Treatment of single maxillary gingival recession associated with non-carious cervical lesion: Randomized clinical trial comparing connective tissue graft alone to graft plus partial restoration. J Clin Periodontol. 2018 Aug;45(8):968-976. doi: 10.1111/jcpe.12907. Epub 2018 Jun 25.