- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04922086
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
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
24
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Test group
Patients will be submitted to ACL planned using cone beam computed tomography (CBCT), digital planning and guided dual technique.
|
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.
|
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
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
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
Investigators
- 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)
September 19, 2019
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
August 1, 2021
Study Registration Dates
First Submitted
May 14, 2021
First Submitted That Met QC Criteria
June 4, 2021
First Posted (Actual)
June 10, 2021
Study Record Updates
Last Update Posted (Actual)
May 10, 2024
Last Update Submitted That Met QC Criteria
May 8, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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