Effect of Restoration Margin Level in the Treatment of Gingival Recession Associated With Non-carious Cervical Lesion

NCT05682274 | Unknown DMC

• 1 other identifier: E-21071282-050.99-108427
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized, parallel-group clinical trial was to compare the 1-year periodontal, root coverage, esthetic, and patient-centered outcomes of the partial restoration placement with different apical margin levels combined with coronally advanced flap (CAF) plus connective tissue graft (CTG) in the treatment of isolated gingival recessions associated with non-carious cervical lesions (NCCL). Forty patients with single gingival recessions (RT1 gingival recessions and class B+ NCCL) were randomly allocated to either placement of restoration apical margin at the level of estimated cementoenamel junction (CEJ) or within 1 mm apical to the CEJ. Two weeks after the restorative treatment, all recession defects were treated with CAF combined with CTG. Periodontal measurements were taken at baseline, and 3, 6, and 12 months postoperatively. Patient-centered outcomes were evaluated at baseline, and 7, and 15 days, 6, and 12 months postoperative follow-ups. Modified root closure aesthetic score (mRES) was used to assess aesthetics at 6 and 12 months follow-ups.

Conditions

Gingival Recession, Localized

Keywords

Gingival recession; Tooth abrasion; Composite resin; Connective tissue graft; Dental sensitivity

Outcome Measures

Primary Outcomes (1)

• Change in gingival recession height

  Immediately after reconstruction of CEJ, gingival recession height was measured and accepted as baseline value. This value was obtained by the difference between 12th month gingival recession height and baseline recession height

  12 months after the surgery

Secondary Outcomes (8)

• Mean root coverage

  12 months after the surgery

• Complete root coverage

  12 months after the surgery

• Modified root closure aesthetic score

  12 months after the surgery

• Dental sensitivity by visual analogue scale

  12 months after the surgery

• Self-perceived aesthetic satisfaction by visual analogue scale

  12 months after the surgery

Study Arms (2)

Group I

ACTIVE COMPARATOR

Partial restoration with the apical border at the level of CEJ in combination with CAF+CTG

Procedure: Partial restoration approach combined with CAF+CTG

Group II

ACTIVE COMPARATOR

Partial restoration with the apical border within 1 mm apical to the CEJ.

Procedure: Partial restoration approach combined with CAF+CTG

Interventions

Partial restoration approach combined with CAF+CTG PROCEDURE

The location of the CEJ prior to the restorative treatment was identified using the method developed by Zuchelli et al. 2006. The placement of the apical margin of the restoration was performed either at the level of estimated cementoenamel junction (CEJ) or within 1 mm apical to the CEJ. Two weeks after the restorative treatment, all recession defects were treated with CAF combined with CTG.

Group I; Group II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gingival recession of at least 1 mm depth.
• There is no loss of interdental support (RT-1)
• Cervical step greater than 0.5 mm
• Inability to detect CEJ (Class B+)
• Maximum root closure level at the NCCL's deepest point (Type 3)
• Individuals who do not have any systemic disease that would preclude surgery
• Who are not pregnant
• Who are not smokers or who smoke less than 5 cigarettes per day
• Who have a whole mouth plaque and bleeding score of 10%
• Patients who do not require endodontic treatment in the surgical area and do not have tooth mobility;
• Patients who do not require orthodontic treatment;
• Patients who do not have periodontal disease; and
• Patients who do not have restoration and/or filling in the recession area.

You may not qualify if:

• Smokers
• Pregnant
• Having a systemic disease that may deteriorate wound healing
• Poor oral hygiene
• Patients with active periodontal disease
• Tooth devitalization

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Dentistry

Ankara, 06490, Turkey (Türkiye)

Location

Related Publications (9)

• 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: 21542735 RESULT

• Yang S, Lee H, Jin SH. A combined approach to non-carious cervical lesions associated with gingival recession. Restor Dent Endod. 2016 Aug;41(3):218-24. doi: 10.5395/rde.2016.41.3.218. Epub 2016 May 2.

  PMID: 27508164 RESULT

• Cairo F, Cortellini P, Nieri M, Pilloni A, Barbato L, Pagavino G, Tonetti M. Coronally advanced flap and composite restoration of the enamel with or without connective tissue graft for the treatment of single maxillary gingival recession with non-carious cervical lesion. A randomized controlled clinical trial. J Clin Periodontol. 2020 Mar;47(3):362-371. doi: 10.1111/jcpe.13229. Epub 2020 Jan 7.

  PMID: 31811742 RESULT

• de Sanctis M, Di Domenico GL, Bandel A, Pedercini C, Guglielmi D. The Influence of Cementoenamel Restorations in the Treatment of Multiple Gingival Recession Defects Associated with Noncarious Cervical Lesions: A Prospective Study. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):333-342. doi: 10.11607/prd.4639.

  PMID: 32233184 RESULT

• Pini-Prato G, Franceschi D, Cairo F, Nieri M, Rotundo R. Classification of dental surface defects in areas of gingival recession. J Periodontol. 2010 Jun;81(6):885-90. doi: 10.1902/jop.2010.090631.

  PMID: 20450362 RESULT

• Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.

  PMID: 19335093 RESULT

• Cairo F, Pini-Prato GP. A technique to identify and reconstruct the cementoenamel junction level using combined periodontal and restorative treatment of gingival recession. A prospective clinical study. Int J Periodontics Restorative Dent. 2010 Dec;30(6):573-81.

  PMID: 20967303 RESULT

• Zucchelli G, Testori T, De Sanctis M. Clinical and anatomical factors limiting treatment outcomes of gingival recession: a new method to predetermine the line of root coverage. J Periodontol. 2006 Apr;77(4):714-21. doi: 10.1902/jop.2006.050038.

  PMID: 16584355 RESULT

• Santamaria MP, Queiroz LA, Mathias IF, Neves FL, Silveira CA, Bresciani E, Jardini MA, Sallum EA. Resin composite plus connective tissue graft to treat single maxillary gingival recession associated with non-carious cervical lesion: randomized clinical trial. J Clin Periodontol. 2016 May;43(5):461-8. doi: 10.1111/jcpe.12524. Epub 2016 Apr 13.

  PMID: 26847486 RESULT

MeSH Terms

Conditions

Gingival Recession; Tooth Abrasion

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Tooth Wear; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 25, 2022
• First Posted: January 12, 2023
• Study Start: October 1, 2021
• Primary Completion: January 20, 2023
• Study Completion: February 1, 2023
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)