NCT02817763

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 7, 2017

Completed
Last Updated

December 11, 2017

Status Verified

November 1, 2017

Enrollment Period

1.7 years

First QC Date

June 27, 2016

Results QC Date

May 11, 2017

Last Update Submit

November 8, 2017

Conditions

Gingival RecessionTooth Abrasion

Outcome Measures

Primary Outcomes (1)

  • Percentage of Defect Coverage

    Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.

    6 months

Secondary Outcomes (1)

  • Modified Root Coverage Esthetic Score (MRES)

    6 months

Study Arms (2)

Connective tissue graft (CTG)

ACTIVE COMPARATOR

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.

Procedure: Connective tissue graft (CTG)Drug: sodium dipyrone

CTG plus resin composite restoration

EXPERIMENTAL

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.

Procedure: CTG plus resin composite restorationDrug: sodium dipyrone

Interventions

Connective tissue graft (CTG)PROCEDURE

Periodontal surgical technique to treat gingival recessions

Also known as: Periodontal plastic surgery
Connective tissue graft (CTG)
CTG plus resin composite restorationPROCEDURE

Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss

Also known as: Periodontal plastic surgery
CTG plus resin composite restoration
sodium dipyroneDRUG

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

CTG plus resin composite restorationConnective tissue graft (CTG)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 23368948BACKGROUND

  • 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.

    PMID: 19594663BACKGROUND

  • 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.

    PMID: 21542735BACKGROUND

  • 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.

    PMID: 29681059DERIVED

MeSH Terms

Conditions

Gingival RecessionTooth Abrasion

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal AtrophyTooth WearTooth Diseases

Results Point of Contact

Title
Dr. Mauro P. Santamaria
Organization
Institute of Science and Technology of São José dos Campos (Unesp)
mauro.santamaria@ict.unesp.br
+55 (16) 981937777

Study Officials

  • Mauro P Santamaria, PhD

    ICT-UNESP

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 27, 2016

First Posted

June 29, 2016

Study Start

February 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

December 11, 2017

Results First Posted

June 7, 2017

Record last verified: 2017-11