Insufficient Clinical Crown LengthNCT06633822
Crown Lengthening in Aesthetic Anterior Sector by Means of Guided Digital Planning: Ramdomized Controlled Clinical Trial.
A study testing Digital planning and Analogic planning in people with Insufficient Clinical Crown Length, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insufficient Clinical Crown Length
- What is being tested?
- Digital planning and Analogic planning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2024to Jun 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mariano Sanz Alonso, MD,DDS,MSc,PhD contact
Spain1 site, 1 recruiting
- Recruiting
Universidad Complutense de Madrid, Dentistry department
Madrid, Madrid, 28040
Georgina Carbajo, DDS,MSc, +34 660437502, geocarba@ucm.es
Georgina Carbajo, DDS,MSc
About this study
Official title: Crown Lengthening in Aesthetic Anterior Sector by Means of Guided Digital Planning: 12-month Randomized Controlled Clinical Trial Comparing the Efficacy of Digital Versus Analog Protocol.
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.
Read the detailed description
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
- Insufficient Clinical Crown Length
- Being tested
- Digital planning, Analogic planning
- Keywords
- Crown lengthening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital planningDiagnostic 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 planningDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Digital plannig | Experimental | Not described Receives: Diagnostic Test: Digital planning |
| Analogic planning | Active comparator | Not described Receives: Diagnostic Test: Analogic planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of surgical guide.
The accuracy of surgical guide to detect the cementoenamel junction and position of the alveolar bone crest: distance from the splint margin to the CEJ measured intra-surgically in mm at 3 points per tooth using a CP-15 periodontal probe (Hu Friedy®, Leimen, Germany).
Measured: 12 months
Secondary outcomes (5)
The stability of the crown length
The stability of the crown length established over a 12-month period (tissue rebound) measured at 3 points per tooth with a CP-15 millimeter periodontal probe and by intraoral digital scanning.
Measured: 12 months
Patient's phenotype
Therapeutic response according to the patient's phenotype, based on the transparency of the periodontal probe CP-15 (Hu Friedy®, Leimen, Germany) through the gingival margin while probing the buccal sulcus, according to the classification of Rouck et al 2009.
Measured: 12 months
The number of teeth and patients in which the second phase was necessary.
The number of teeth and patients in which the second phase was necessary and the amount of removal of keratinized tissue (gingivectomy) in the second phase (at 4 months) in millimeters using a CP-15 millimeter periodontal probe.
Measured: 12 months
The time spent
The time spent in digital/analog recording in minutes.
Measured: 12 months
Patient satisfaction
Patient satisfaction according to the validated survey (Oral Health Impact Profile OHIP-14).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Feb 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insufficient Clinical Crown LengthStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633822
- Sponsor's protocol ID
- 24/160-E
- Status last verified
- Feb 2024
- First submitted
- 8 Jul 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crown Lengthening in Aesthetic Anterior Sector by Means of Guided Digital Planning: 12-month Randomized Controlled Clinical Trial Comparing the Efficacy of Digital Versus Analog Protocol.
- ClinicalTrials.gov ID
- NCT06633822
- Acronym / sponsor ID
- 24/160-E
- Conditions
- Insufficient Clinical Crown Length
- Keywords
- Crown lengthening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Oct 2024 (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.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital plannig | Experimental | Diagnostic Test: Digital planning |
| Analogic planning | Active comparator | Diagnostic Test: Analogic planning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Digital planningThe 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. | Diagnostic test | Digital plannig |
| Analogic planningThe 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. | Diagnostic test | Analogic planning |
Primary outcome
The accuracy of surgical guide.
Time frame: 12 months
The accuracy of surgical guide to detect the cementoenamel junction and position of the alveolar bone crest: distance from the splint margin to the CEJ measured intra-surgically in mm at 3 points per tooth using a CP-15 periodontal probe (Hu Friedy®, Leimen, Germany).
5 secondary outcomes
The stability of the crown length
Time frame: 12 months
Patient's phenotype
Time frame: 12 months
The number of teeth and patients in which the second phase was necessary.
Time frame: 12 months
The time spent
Time frame: 12 months
Patient satisfaction
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
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.
Mariano Sanz Alonso, MD,DDS,MSc,PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital planning and Analogic planning in people with Insufficient Clinical Crown Length, run by Universidad Complutense de Madrid at 1 site in Spain.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Oct 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgina Carbajo, DDS,MSc (+34 660437502, geocarba@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of surgical guide. (time frame: 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 9 Oct 2024.