Crown Lengthening in Aesthetic Anterior Sector by Means of Guided Digital Planning: Ramdomized Controlled Clinical Trial.

Not Applicable

Recruiting

• Conditions: Insufficient Clinical Crown Length
• Interventions: Diagnostic Test: Digital planning; Diagnostic Test: Analogic planning

• Registration Number: NCT06633822
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

The objective of this research is to compare the diagnostic accuracy in the detection of the cementoenamel junction (CEJ) and alveolar bone ridge using guided digital planning versus conventional analog planning for patients with excessive gingival exposure in the smile (gummy smile) due, at least in part, to altered passive eruption.

Detailed Description

Forty-four subjects will be randomly assigned to the planning groups according to a digital methodology, DM (n=22) or an analog methodology AM (n=22). Surgical guides will be developed to establish the location of the acementoenamel junction and bone crest. The digital methodology will consist of obtaining a digital scan and a computed tomography (CBCT) that will be aligned using a digital program for the elaboration of a digital wax-up and fabrication of a printed surgical template. The analog wax-up will be elaborated based on a silicone impression and periapical radiographs with parallel technique, which will allow us to elaborate an essix type surgical splint. Measurements will be recorded at baseline, on the day of surgery, at 4, 6 and 12 months of follow-up. Variables related to the patient's experience will also be recorded.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-01
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Over 18 years of age
• Presence of teeth in the second sextant (edentulous section of a single tooth with the presence of adjacent teeth on both sides of the absence is accepted).
• No sites with attachment loss (AL) > 3 mm in the area to be treated (second sextant).
• Present full mouth plaque index (Ainamo and Bay, 1975) <15%.
• Have bleeding on probing (BoP; Ainamo & Bay 1975) <15%.

Exclusion Criteria

• pregnancy or lactation
• patients who smoke
• patients under treatment with antimicrobials and anti-inflammatory drugs in the last 2 months or with medications associated with changes in the gingival tissue (antiepileptics, calcium channel blockers, etc.)
• subjects with systemic conditions that alter the normal presentation of the gingival tissue (hereditary gingival fibromatosis) or those diagnosed with uncontrolled diabetes mellitus
• patients with severe dental malposition and/or presence of dental implants in the area to be treated
• use of orthodontic appliances
• all those who present a disability or mental disorders that make it difficult for the patient to understand or follow them during the study period. study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital plannig	Digital planning	-
Analogic planning	Analogic planning	-

Primary Outcome Measures

Name	Time	Method
The accuracy of surgical guide.	12 months	The accuracy of surgical guide to detect the cementoenamel junction and position of the alveolar bone crest: distance from the splint margin to the CEJ measured intra-surgically in mm at 3 points per tooth using a CP-15 periodontal probe (Hu Friedy®, Leimen, Germany).

Secondary Outcome Measures

Name	Time	Method
The stability of the crown length	12 months	The stability of the crown length established over a 12-month period (tissue rebound) measured at 3 points per tooth with a CP-15 millimeter periodontal probe and by intraoral digital scanning.
Patient's phenotype	12 months	Therapeutic response according to the patient's phenotype, based on the transparency of the periodontal probe CP-15 (Hu Friedy®, Leimen, Germany) through the gingival margin while probing the buccal sulcus, according to the classification of Rouck et al 2009.
The number of teeth and patients in which the second phase was necessary.	12 months	The number of teeth and patients in which the second phase was necessary and the amount of removal of keratinized tissue (gingivectomy) in the second phase (at 4 months) in millimeters using a CP-15 millimeter periodontal probe.
The time spent	12 months	The time spent in digital/analog recording in minutes.
Patient satisfaction	12 months	Patient satisfaction according to the validated survey (Oral Health Impact Profile OHIP-14).

Trial Locations

Locations (1)

Universidad Complutense de Madrid, Dentistry department; 🇪🇸 Madrid, Spain