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Digital Planning and Guided Dual Technique in Aesthetic Crown Lengthening

Primary Purpose

Tooth Eruption Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Conventional aesthetic crown lengthening surgery
Guided dual aesthetic crown lengthening surgery
Sponsored by
Universidade Federal de Alfenas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Eruption Disorder focused on measuring Crown Lengthening, Altered passive eruption, Gingival smile

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Non smokers;
  • Periodontal and systemically healthy;
  • Patients with more than 20 teeth including the six maxillary anterior teeth;
  • Altered passive eruption diagnosis (classified as type I subcategory B) in the quadratic anterior teeth.

Exclusion Criteria:

  • Orthodontic treatment;
  • Presence of prosthetic crowns;
  • Extensive restorations;
  • Extensive incisal edge attrition;
  • Misalignment on maxillary anterior teeth.

Sites / Locations

  • Universidade Federal de Alfenas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test group

Control group

Arm Description

Patients will be submitted to ACL planned using cone beam computed tomography (CBCT), digital planning and guided dual technique.

Patients will be submitted to the conventional ACL planned using clinical examination.

Outcomes

Primary Outcome Measures

Change of clinical crown length.
Measured as the distance between incisal edge and gingival marginal using a periodontal probe and its will determine the stability of the gingival margin in the both groups. The clinical crown length will be also measured using a cone beam computed tomography (CBCT)

Secondary Outcome Measures

Change of gingival display.
Measured as the distance between central incisor gingival margin during active smile and the inferior border of the upper lip vermilion using a periodontal probe.
Change of gingival width.
Measured as the distance between mucogingival junction and gingival margin, using the visual method.
Change of gingival margin position.
Measured as the cemento-enamel junction to gingival margin distance using a periodontal probe.
Change of gingival thickness.
Measured at the 3mm apical of gingival margin with a endodontics file inserted perpendicular to the surface until firm resistance was met, and recorded to the nearest millimetre using a digital caliber. The gingival thickness will be also measured using a cone beam computed tomography (CBCT).
Change of anatomic crown length.
Measured after flap elevation as the distance between incisal edge and cemento-enamel junction, along the long axis of the tooth using a periodontal probe and cone beam computed tomography (CBCT).
Distance between cemento-enamel junction and bone crest.
Measured of the distance between cemento-enamel junction and bone crest using a periodontal probe and cone beam computed tomography (CBCT).
Change of probing depth.
Measured as the distance between gingival margin and bottom of the gingival sulcus using a periodontal probe.
Change of clinical attachment level
Measured as the distance between cemento-enamel junction and bottom of the sulcus using a periodontal probe.

Full Information

First Posted
May 14, 2021
Last Updated
September 28, 2021
Sponsor
Universidade Federal de Alfenas
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1. Study Identification

Unique Protocol Identification Number
NCT04922086
Brief Title
Digital Planning and Guided Dual Technique in Aesthetic Crown Lengthening
Official Title
The Effectiveness of Digital Planning and Guided Dual Technique in Aesthetic Crown Lengthening: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Federal de Alfenas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Excessive gingival exposure, commonly named gingival smile, results in a dentogingival disharmony. One of the gingival smile treatment is the aesthetics-related crown lengthening surgery (ACL) to provide a adequate clinical crown length and diminish gingival display. In this context, digital planning and guided dual technique have been proposed to increase the effectiveness and predictability of the ACL. In this technique, an facial and dental analysis of the patient is performed and transferred to a digital model obtained by intraoral digital scan. The digital model is used to create a double guide that will determine the final position of the gingival and alveolar margin in the ACL. Despite the technique showing promising results, clinical studies evaluating the effectiveness of this technique are scarce. The present study aims to evaluate the digital planning and guided dual technique in the ACL in comparison to conventional technique in relation to the predictability/stability of the gingival margin positioning and patient satisfaction after the ACL. Twenty-four patients diagnosed with altered passive eruption type I subcategory B will be selected and divided into two groups. In the control group (n = 12) patients will be submitted to the conventional ACL planned using clinical examination; in the test group (n = 12) patients will be submitted to ACL using cone beam computed tomography (CBCT), digital planning and guided dual technique. Periodontal clinical parameters including probing depth (PS), clinical attachment level (CAL), clinical crown length (CCL), anatomical crown length (ACL) and cemento-enamel junction to alveolar bone crest distance will be evaluated clinically at baseline, in the immediate postoperative, 4, 8 and 12 months after the procedure. Participants will be submitted to questionnaires to assess satisfaction with the smile, gum and tooth characteristics and experience with the procedure. The investigators aim to demonstrate with the study the effectiveness of the both techniques and evaluate the clinical cost benefit for the patient and the dentist of the guided dual technique in relation to the conventional ACL technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Eruption Disorder
Keywords
Crown Lengthening, Altered passive eruption, Gingival smile

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
Patients will be submitted to ACL planned using cone beam computed tomography (CBCT), digital planning and guided dual technique.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients will be submitted to the conventional ACL planned using clinical examination.
Intervention Type
Procedure
Intervention Name(s)
Conventional aesthetic crown lengthening surgery
Intervention Description
The demarcation of the gingival zenith final position will be done on the teeth using a periodontal probe. This demarcation will be done through visual examination based on the crown length/width ratio and the position of the cemento-enamel junction (CEJ). The gingival margin of the central and canine incisors will be positioned at similar heights and a more coronal gingival contour will be determined for the lateral incisors. An internal bevel incision will be made with a blade on each tooth, preserving the interdental papillae. The incised gingival tissue will be removed using a periodontal curette in both groups. An internal bevel incision will be made in the involved teeth and a full thickness flap will be displaced up to the the mucogingival junction level to expose the bone crest (BC). Carbide drills and manual chisels will be used for bone resection to obtained a CEJ-BC distance of 3 mm. Simple interproximal interrupted sutures will be performed.
Intervention Type
Procedure
Intervention Name(s)
Guided dual aesthetic crown lengthening surgery
Intervention Description
The double guide will be positioned and an internal bevel incision on each tooth will be made following the guide demarcation. After the initial incision, the incised gingival tissue will be removed using a periodontal curette. An internal bevel incision will be made in the involved teeth and a full thickness flap will be displaced up to the the mucogingival junction level to expose the bone crest (BC). The dual guide will be positioned again and the bone tissue will be removed using carbide drills and manual chisels following the double guide. No interproximal crestal bone will be removed. Simple interproximal interrupted sutures will be performed to stabilize the flap.
Primary Outcome Measure Information:
Title
Change of clinical crown length.
Description
Measured as the distance between incisal edge and gingival marginal using a periodontal probe and its will determine the stability of the gingival margin in the both groups. The clinical crown length will be also measured using a cone beam computed tomography (CBCT)
Time Frame
Baseline, immediately after the intervention, 4, 8 and 12 months.
Secondary Outcome Measure Information:
Title
Change of gingival display.
Description
Measured as the distance between central incisor gingival margin during active smile and the inferior border of the upper lip vermilion using a periodontal probe.
Time Frame
Baseline, 4, 8 and 12 months.
Title
Change of gingival width.
Description
Measured as the distance between mucogingival junction and gingival margin, using the visual method.
Time Frame
Baseline, immediately after the intervention, 4, 8 and 12 months.
Title
Change of gingival margin position.
Description
Measured as the cemento-enamel junction to gingival margin distance using a periodontal probe.
Time Frame
Baseline, 4, 8 and 12 months.
Title
Change of gingival thickness.
Description
Measured at the 3mm apical of gingival margin with a endodontics file inserted perpendicular to the surface until firm resistance was met, and recorded to the nearest millimetre using a digital caliber. The gingival thickness will be also measured using a cone beam computed tomography (CBCT).
Time Frame
Baseline.
Title
Change of anatomic crown length.
Description
Measured after flap elevation as the distance between incisal edge and cemento-enamel junction, along the long axis of the tooth using a periodontal probe and cone beam computed tomography (CBCT).
Time Frame
During the intervention.
Title
Distance between cemento-enamel junction and bone crest.
Description
Measured of the distance between cemento-enamel junction and bone crest using a periodontal probe and cone beam computed tomography (CBCT).
Time Frame
During the intervention.
Title
Change of probing depth.
Description
Measured as the distance between gingival margin and bottom of the gingival sulcus using a periodontal probe.
Time Frame
Baseline, 4, 8 and 12 months.
Title
Change of clinical attachment level
Description
Measured as the distance between cemento-enamel junction and bottom of the sulcus using a periodontal probe.
Time Frame
Baseline, 4, 8 and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Non smokers; Periodontal and systemically healthy; Patients with more than 20 teeth including the six maxillary anterior teeth; Altered passive eruption diagnosis (classified as type I subcategory B) in the quadratic anterior teeth. Exclusion Criteria: Orthodontic treatment; Presence of prosthetic crowns; Extensive restorations; Extensive incisal edge attrition; Misalignment on maxillary anterior teeth.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzane C Pigossi, PhD
Organizational Affiliation
Universidade Federal de Alfenas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Alfenas
City
Alfenas
State/Province
Minas Gerais
ZIP/Postal Code
37130-013
Country
Brazil

12. IPD Sharing Statement

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Digital Planning and Guided Dual Technique in Aesthetic Crown Lengthening

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