Digital Planning and Guided Dual Technique in Aesthetic Crown Lengthening

May 8, 2024 updated by: Universidade Federal de Alfenas

The Effectiveness of Digital Planning and Guided Dual Technique in Aesthetic Crown Lengthening: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Alfenas, Minas Gerais, Brazil, 37130-013
        • Universidade Federal de Alfenas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test group
Patients will be submitted to ACL planned using cone beam computed tomography (CBCT), digital planning and guided dual technique.
Procedure: Guided dual aesthetic crown lengthening surgery
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.
Active Comparator: Control group
Patients will be submitted to the conventional ACL planned using clinical examination.
Procedure: Conventional aesthetic crown lengthening surgery
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of clinical crown length.
Time Frame: Baseline, immediately after the intervention, 4, 8 and 12 months.
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)
Baseline, immediately after the intervention, 4, 8 and 12 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of gingival display.
Time Frame: Baseline, 4, 8 and 12 months.
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.
Baseline, 4, 8 and 12 months.
Change of gingival width.
Time Frame: Baseline, immediately after the intervention, 4, 8 and 12 months.
Measured as the distance between mucogingival junction and gingival margin, using the visual method.
Baseline, immediately after the intervention, 4, 8 and 12 months.
Change of gingival margin position.
Time Frame: Baseline, 4, 8 and 12 months.
Measured as the cemento-enamel junction to gingival margin distance using a periodontal probe.
Baseline, 4, 8 and 12 months.
Change of gingival thickness.
Time Frame: Baseline.
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).
Baseline.
Change of anatomic crown length.
Time Frame: During the intervention.
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).
During the intervention.
Distance between cemento-enamel junction and bone crest.
Time Frame: During the intervention.
Measured of the distance between cemento-enamel junction and bone crest using a periodontal probe and cone beam computed tomography (CBCT).
During the intervention.
Change of probing depth.
Time Frame: Baseline, 4, 8 and 12 months.
Measured as the distance between gingival margin and bottom of the gingival sulcus using a periodontal probe.
Baseline, 4, 8 and 12 months.
Change of clinical attachment level
Time Frame: Baseline, 4, 8 and 12 months.
Measured as the distance between cemento-enamel junction and bottom of the sulcus using a periodontal probe.
Baseline, 4, 8 and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Alfenas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Suzane C Pigossi, PhD, Universidade Federal de Alfenas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACL - UNIFAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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