Clinical trial NCT06633822: Crown Lengthening in Aesthetic Anterior Sector by Means of Guided Digital Planning: Ramdomized Controlled Clinical Trial.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insufficient Clinical Crown Length
Keywords: Crown lengthening
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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%.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The accuracy of surgical guide.
timeFrame: 12 months
Secondary outcomes:
measure: The stability of the crown length
timeFrame: 12 months
measure: Patient's phenotype
timeFrame: 12 months
measure: The number of teeth and patients in which the second phase was necessary.
timeFrame: 12 months
measure: The time spent
timeFrame: 12 months
measure: Patient satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid, Dentistry department
Study officials:
References: