Tooth Eruption DisorderNCT04922086
Digital Planning and Guided Dual Technique in Aesthetic Crown Lengthening
A study testing Conventional aesthetic crown lengthening surgery and Guided dual aesthetic crown lengthening surgery in people with Tooth Eruption Disorder, run by Universidade Federal de Alfenas at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Eruption Disorder
- What is being tested?
- Conventional aesthetic crown lengthening surgery and Guided dual aesthetic crown lengthening surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Sep 2019to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Orthodontic treatment;
- Presence of prosthetic crowns;
- Extensive restorations;
- Extensive incisal edge attrition;
- Misalignment on maxillary anterior teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tooth Eruption Disorder
- Being tested
- Conventional aesthetic crown lengthening surgery, Guided dual aesthetic crown lengthening surgery
- Keywords
- Crown Lengthening, Altered passive eruption, Gingival smile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional aesthetic crown lengthening surgeryProcedure or 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.
Guided dual aesthetic crown lengthening surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Patients will be submitted to ACL planned using cone beam computed tomography (CBCT), digital planning and guided dual technique. Receives: Procedure: Guided dual aesthetic crown lengthening surgery |
| Control group | Active comparator | Patients will be submitted to the conventional ACL planned using clinical examination. Receives: Procedure: Conventional aesthetic crown lengthening surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, immediately after the intervention, 4, 8 and 12 months.
Secondary outcomes (8)
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.
Measured: Baseline, 4, 8 and 12 months.
Change of gingival width.
Measured as the distance between mucogingival junction and gingival margin, using the visual method.
Measured: Baseline, immediately after the intervention, 4, 8 and 12 months.
Change of gingival margin position.
Measured as the cemento-enamel junction to gingival margin distance using a periodontal probe.
Measured: Baseline, 4, 8 and 12 months.
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).
Measured: Baseline.
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).
Measured: During the intervention.
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).
Measured: During the intervention.
Change of probing depth.
Measured as the distance between gingival margin and bottom of the gingival sulcus using a periodontal probe.
Measured: Baseline, 4, 8 and 12 months.
Change of clinical attachment level
Measured as the distance between cemento-enamel junction and bottom of the sulcus using a periodontal probe.
Measured: Baseline, 4, 8 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start19 Sep 2019
- Primary completion1 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Eruption DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Alfenas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzane C Pigossi, PhD, Principal investigator, Universidade Federal de Alfenas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922086
- Sponsor's protocol ID
- ACL - UNIFAL
- Status last verified
- May 2024
- First submitted
- 14 May 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Digital Planning and Guided Dual Technique in Aesthetic Crown Lengthening: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04922086
- Acronym / sponsor ID
- ACL - UNIFAL
- Conditions
- Tooth Eruption Disorder
- Keywords
- Crown Lengthening, Altered passive eruption, Gingival smile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade Federal de AlfenasUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Guided dual aesthetic crown lengthening surgeryPatients will be submitted to ACL planned using cone beam computed tomography (CBCT), digital planning and guided dual technique. |
| Control group | Active comparator | Procedure: Conventional aesthetic crown lengthening surgeryPatients will be submitted to the conventional ACL planned using clinical examination. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Orthodontic treatment;
- Presence of prosthetic crowns;
- Extensive restorations;
- Extensive incisal edge attrition;
- Misalignment on maxillary anterior teeth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional aesthetic crown lengthening surgeryThe 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. | Procedure or surgery | Control group |
| Guided dual aesthetic crown lengthening surgeryThe 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. | Procedure or surgery | Test group |
Primary outcome
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)
8 secondary outcomes
Change of gingival display.
Time frame: Baseline, 4, 8 and 12 months.
Change of gingival width.
Time frame: Baseline, immediately after the intervention, 4, 8 and 12 months.
Change of gingival margin position.
Time frame: Baseline, 4, 8 and 12 months.
Change of gingival thickness.
Time frame: Baseline.
Change of anatomic crown length.
Time frame: During the intervention.
Distance between cemento-enamel junction and bone crest.
Time frame: During the intervention.
Change of probing depth.
Time frame: Baseline, 4, 8 and 12 months.
Change of clinical attachment level
Time frame: Baseline, 4, 8 and 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzane C Pigossi, PhD principal investigator
Universidade Federal de Alfenas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional aesthetic crown lengthening surgery and Guided dual aesthetic crown lengthening surgery in people with Tooth Eruption Disorder, run by Universidade Federal de Alfenas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of clinical crown length. (time frame: Baseline, immediately after the intervention, 4, 8 and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.