Clinical Trial: Flapless Esthetic Crown Lengthening for the Treatment of Excessive Gingival Display

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open-flap Versus Flapless Esthetic Crown Lengthening: 12-month Clinical Outcomes of a Randomized Controlled Clinical Trial

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).

Detailed Summary:

Experimental design and treatment protocols

In this prospective, split-mouth, randomized controlled clinical study, 28 subjects (21 - 40 years old) requiring correction of EGD will received ECL using OF and FL techniques. A computer-generated table randomly distributed the right quadrant to receive OF or FL techniques. Consequently, the contralateral left quadrant was allocated to the other group. The following treatments were performed:

OF (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.

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.

After both procedures, canines and central incisors should be at the same length, and the lateral incisor should be 1mm shorter. The same periodontist (F.R.V.) performed all
Sponsor: University of Guarulhos

Current Primary Outcome: Mean changes in gingival margin [ Time Frame: Baseline to 3, 6 and 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visible plaque accumulation [ Time Frame: Baseline, 3, 6 and 12 months ]
  • Marginal bleeding [ Time Frame: Baseline, 3, 6 and 12 months ]
  • Bleeding on probing [ Time Frame: Baseline, 3, 6 and 12 months ]
  • Probing depth [ Time Frame: Baseline, 3, 6 and 12 months ]
  • Clinical attachment level [ Time Frame: Baseline, 3, 6 and 12 months ]
  • Keratinized gingiva height [ Time Frame: Baseline, 3, 6 and 12 months ]
  • Patient perceptions [ Time Frame: Baseline, 7 days and 6 months ]
  • RANKL levels [ Time Frame: Baseline and 3 months ]
  • OPG levels [ Time Frame: Baseline and 3 months ]


Original Secondary Outcome: Visible plaque accumulation, marginal bleeding, bleeding on probing, probing depth, clinical attachment level, keratinized gingiva height, patient perceptions and RANKL and OPG levels [ Time Frame: Baseline, 3, 6 and 12 months ]

Information By: University of Guarulhos

Dates:
Date Received: March 26, 2013
Date Started: January 2011
Date Completion:
Last Updated: March 29, 2013
Last Verified: March 2013