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

NCT ID: NCT06633822

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Insufficient Clinical Crown Length

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Digital plannig

Group Type EXPERIMENTAL

Digital planning

Intervention Type DIAGNOSTIC_TEST

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.

Analogic planning

Group Type ACTIVE_COMPARATOR

Analogic planning

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universidad Complutense de Madrid, Dentistry department

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Georgina Carbajo, DDS,MSc

Role: CONTACT

+34 660437502

Mariano Sanz Alonso, MD,DDS,MSc,PhD

Role: CONTACT

Facility Contacts

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Georgina Carbajo, DDS,MSc

Role: primary

+34 660437502

Georgina Carbajo, DDS,MSc

Role: backup

Mariano Sanz Alonso, MD,DDS,MSc,PhD

Role: backup

Gustavo Avila, DDS,MSc

Role: backup

Oscar Gonzalez, DDS,MSc

Role: backup

Other Identifiers

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24/160-E

Identifier Type: -

Identifier Source: org_study_id

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