Flapless Esthetic Crown Lengthening for the Treatment of Excessive Gingival Display

NCT01821157 | Completed DMC

• 2 other identifiers: SISNEP/611209/2010
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the clinical outcomes of open-flap (OF) and flapless (FL) esthetic crown lengthening (ECL) for the treatment of excessive gingival display (EGD). It was hypothesized that the FL surgery would yield similar clinical results to the OF technique up to 12 months. Methods: A split-mouth randomized controlled trial will be conducted in 28 subjects presenting EGD. Contralateral quadrants will receive ECL using OF or FL techniques. Clinical parameters will be evaluated at baseline, 3, 6 and 12 months post-surgeries. The local levels of receptor activator of NF-КB ligand (RANKL) and osteoprotegerin (OPG) will be assessed by ELISA at baseline and 3 months. Patients' perceptions regarding morbidity and esthetical appearance will be also evaluated. Periodontal tissue dimensions will be obtained by computed tomography at baseline and correlated with the changes in the gingival margin (GM).

Conditions

Gingival Overgrowth

Keywords

crown lengthening; gingivoplasty; surgical procedures; gingivectomy; esthetic surgery

Outcome Measures

Primary Outcomes (1)

• Mean changes in gingival margin

  Baseline to 3, 6 and 12 months

Secondary Outcomes (9)

• Visible plaque accumulation

  Baseline, 3, 6 and 12 months

• Marginal bleeding

  Baseline, 3, 6 and 12 months

• Bleeding on probing

  Baseline, 3, 6 and 12 months

• Probing depth

  Baseline, 3, 6 and 12 months

• Clinical attachment level

  Baseline, 3, 6 and 12 months

Study Arms (2)

Flapless

ACTIVE COMPARATOR

Flapless: Gingivectomy and osteoplasty, as necessary, will be performed without flap elevation.

Procedure: Flapless

Open-flap

ACTIVE COMPARATOR

Gingivectomy and osteoplasty, as necessary, will be performed with flap elevation

Procedure: Open-flap

Interventions

Open-flap PROCEDURE

Open-flap(control group; n=28 sides/105 teeth): An internal beveled incision was performed at the buccal aspect of the involved teeth. Afterwards, a sulcular incision was completed to allow gingival tissue removal. A full-thickness mucoperiosteal flap was reflected to remove and remodel bone tissue by means of surgical chisels, as necessary, until a 3mm distance was achieved between the bone crest and the cement-enamel junction (CEJ). The exposed root surfaces were carefully planed with curettes. Interrupted sutures were performed at the papilla to allow GM stabilization in the CEJ position.

Open-flap

Flapless PROCEDURE

FL (test group; n=28 sides/105 teeth): Internal beveled and sulcular incisions and gingival tissue removal were performed as above described for the control group, replacing the GM in the CEJ position. However, the alveolar bone was removed and remodeled, as necessary, using micro chisels, via incisions, without flap elevation. The root surfaces were also carefully planed via incisions. The required distance of 3mm between the bone crest and the CEJ was checked by inserting a periodontal probe into the incision. Sutures were not performed.

Flapless

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• esthetic concerns regarding excessive gingival display due to altered passive eruption in at least three upper teeth (incisors, lateral, canines or premolars) per half contralateral quadrant.
• \> 21 years old,
• at least 20 teeth
• no sites with attachment loss and probing depth (PD) \> 3 mm
• full-mouth plaque, bleeding on probing (BoP) and marginal bleeding (MB) index scores of \< 15%

You may not qualify if:

• pregnancy
• lactation
• history of smoking
• antimicrobial and anti-inflammatory therapies in the previous 2 months
• previous mucogingival surgery at the region to be treated
• systemic conditions that could affect tissue healing (e.g. diabetes)
• use of orthodontic appliances

Sponsors & Collaborators

• University of Guarulhos: lead

Study Sites (1)

Guarulhos University

Guarulhos, São Paulo, 07023-070, Brazil

Location

Related Publications (5)

• Levine RA, McGuire M. The diagnosis and treatment of the gummy smile. Compend Contin Educ Dent. 1997 Aug;18(8):757-62, 764; quiz 766.

  PMID: 9533335 BACKGROUND

• Silberberg N, Goldstein M, Smidt A. Excessive gingival display--etiology, diagnosis, and treatment modalities. Quintessence Int. 2009 Nov-Dec;40(10):809-18.

  PMID: 19898712 BACKGROUND

• Rossi R, Benedetti R, Santos-Morales RI. Treatment of altered passive eruption: periodontal plastic surgery of the dentogingival junction. Eur J Esthet Dent. 2008 Autumn;3(3):212-23.

  PMID: 19655539 BACKGROUND

• Rethman MP, Harrel SK. Minimally invasive periodontal therapy: will periodontal therapy remain a technologic laggard? J Periodontol. 2010 Oct;81(10):1390-5. doi: 10.1902/jop.2010.100150.

  PMID: 20476885 BACKGROUND

• Malkinson S, Waldrop TC, Gunsolley JC, Lanning SK, Sabatini R. The effect of esthetic crown lengthening on perceptions of a patient's attractiveness, friendliness, trustworthiness, intelligence, and self-confidence. J Periodontol. 2013 Aug;84(8):1126-33. doi: 10.1902/jop.2012.120403. Epub 2012 Nov 9.

  PMID: 23137007 BACKGROUND

MeSH Terms

Conditions

Gingival Overgrowth

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Poliana M Duarte, DDS

  Guarulhos University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: March 29, 2013
• Study Start: January 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 2, 2013

Record last verified: 2013-03

Locations

BR (1)