One- Versus Two-Stage Aesthetic Crown Lengthening

Not Applicable

Completed

• Conditions: Patients in Need of Surgical CL in the Anterior Maxillary Sextant for Restorative Purposes

• Registration Number: NCT04409366
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

This randomized controlled trial was aimed at assessing the efficacy of a two-stage crown lengthening intervention (SCL) for restorative purposes in the aesthetic zone compared with a one-stage crown lengthening procedure (CCL).

Detailed Description

Subjects were randomly allocated to receive SCL or CCL. SCL consisted of full thickness flaps followed by bone recontouring and minor gingivectomy 4 months postoperatively, if required. In CCL, osseous recontouring after sub-marginal incisions was performed, followed by flap repositioning. Records were obtained at baseline, 4 months (only in SCL), 6 and 12 months. Primary outcome was the precision in achieving a predetermined gingival margin position. Other outcomes were changes in the gingival margin position and keratinized tissue width (KTW) at 12 months, and patient-reported outcomes (PROMs) using the OHIP-14 tool.

Study Timeline

• Study Start: 2013-04-01
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-26
• Last Update Submitted: 2020-05-26
• Study First Posted: 2020-06-01
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• older than eighteen years of age;
• more than 20 teeth in the mouth;
• with full mouth plaque and bleeding scores lower than 15%; and
• without probing pocket depth and/or attachment loss >4 mm

Exclusion Criteria

• Pregnant women or breastfeeding
• smokers
• treated with antimicrobial and/or anti-inflammatory drugs within two months prior to entering the study
• currently undergoing orthodontic therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
T1-T4	Baseline-12 months	The difference in mm between the ideal gingival margin (T1) and the position of the gingival margin at 12 months (T4).

Secondary Outcome Measures

Name	Time	Method
Clinical Crown Length	At baseline, 6- and 12-month	Distance from the gingival margin to the incisal edge on the midbuccal.Measured in mm.
Gingival display upon smiling	At baseline, 6- and 12-month	Distance from the gingival margin of the central incisors to the lower edge of the upper lip. Measured in mm.
Amount of keratinized tissue	At baseline, 6- and 12-month	Distance from the gingival margin to the mucogingival junction on the midbuccal.Measured in mm.
Supracrestal tissue dimension	At baseline, 6- and 12-month	Distance from the gingival margin to the alveolar bone crest (GM-ABC) as determined by bone sounding following local anesthesia. Measured in mm.