search
Back to results

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

Primary Purpose

Gingival Recession, Tooth Abrasion

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Connective tissue graft (CTG)
CTG plus resin composite restoration
sodium dipyrone
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Connective tissue graft (CTG)

    CTG plus resin composite restoration

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    June 27, 2016
    Last Updated
    November 8, 2017
    Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02817763
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession, Tooth Abrasion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Connective tissue graft (CTG)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    CTG plus resin composite restoration
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Connective tissue graft (CTG)
    Other Intervention Name(s)
    Periodontal plastic surgery
    Intervention Description
    Periodontal surgical technique to treat gingival recessions
    Intervention Type
    Procedure
    Intervention Name(s)
    CTG plus resin composite restoration
    Other Intervention Name(s)
    Periodontal plastic surgery
    Intervention Description
    Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss
    Intervention Type
    Drug
    Intervention Name(s)
    sodium dipyrone
    Intervention Description
    sodium dipyrone was recommended for all participants after the surgical procedures.
    Primary Outcome Measure Information:
    Title
    Percentage of Defect Coverage
    Description
    Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Modified Root Coverage Esthetic Score (MRES)
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mauro P Santamaria, PhD
    Organizational Affiliation
    ICT-UNESP
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    23368948
    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.
    Results Reference
    background
    PubMed Identifier
    19594663
    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.
    Results Reference
    background
    PubMed Identifier
    21542735
    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.
    Results Reference
    background
    PubMed Identifier
    29681059
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs