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

Crown Lengthening in Aesthetic Anterior Sector by Means of Guided Digital Planning: 12-month Randomized Controlled Clinical Trial Comparing the Efficacy of Digital Versus Analog Protocol.

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.

Study Overview

• Status: Recruiting
• Conditions: Insufficient Clinical Crown Length
• Intervention / Treatment: Diagnostic test: Digital planning; Diagnostic test: Analogic planning

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 Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georgina Carbajo, DDS,MSc; Phone Number: +34 660437502; Email: geocarba@ucm.es
• Study Contact Backup: Name: Mariano Sanz Alonso, MD,DDS,MSc,PhD; Email: marsan@ucm.es

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Universidad Complutense de Madrid, Dentistry department
    • Contact: Georgina Carbajo, DDS,MSc; Phone Number: +34 660437502; Email: geocarba@ucm.es
    • Contact: Georgina Carbajo, DDS,MSc
    • Contact: Mariano Sanz Alonso, MD,DDS,MSc,PhD
    • Contact: Gustavo Avila, DDS,MSc
    • Contact: Oscar Gonzalez, DDS,MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital plannig	Diagnostic test: Digital planning; 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.
Active Comparator: Analogic planning	Diagnostic test: Analogic planning; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accuracy of surgical guide.	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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The stability of the crown length	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.	12 months
Patient's phenotype	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.	12 months
The number of teeth and patients in which the second phase was necessary.	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.	12 months
The time spent	The time spent in digital/analog recording in minutes.	12 months
Patient satisfaction	Patient satisfaction according to the validated survey (Oral Health Impact Profile OHIP-14).	12 months

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Estimated): October 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Crown lengthening
• Other Study ID Numbers: 24/160-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No