A New Surgical-restorative Approach to Treat Gingival Recessions Associated With Non-carious Cervical Lesions (NCCL)
NCT ID: NCT02817763
Last Updated: 2017-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2014-02-28
2015-12-31
Brief Summary
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Detailed Description
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\- 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Connective tissue graft (CTG)
After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). 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 (CTG)
Periodontal surgical technique to treat gingival recessions
sodium dipyrone
sodium dipyrone was recommended for all participants after the surgical procedures.
CTG plus resin composite restoration
After local anesthesia, 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 beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, 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.
CTG plus resin composite restoration
Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss
sodium dipyrone
sodium dipyrone was recommended for all participants after the surgical procedures.
Interventions
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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
sodium dipyrone
sodium dipyrone was recommended for all participants after the surgical procedures.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Universidade Estadual Paulista Júlio de Mesquita Filho
OTHER
Responsible Party
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Mauro Pedrine Santamaria
Assistant Professor
Principal Investigators
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Mauro P Santamaria, PhD
Role: PRINCIPAL_INVESTIGATOR
ICT-UNESP
References
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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.
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.
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.
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.
Other Identifiers
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UEPJMF 4
Identifier Type: -
Identifier Source: org_study_id