Clinical trial NCT06081296: Dimensional Changes in Alveolar Ridge Preservation
Official title: Dimensional Changes After Different Alveolar Ridge Preservation Techniques for Posterior Region: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alveolar Bone Loss
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: Objective: The objective is to evaluate the dimensional changes of soft tissue and alveolar ridge after extraction of posterior elements with different clinical protocols of alveolar preservation.

Detailed description: Detailed methodology: 80 individuals will be selected with need for extraction of premolar and molar elements, from both arches, for non-periodontal reasons, to participate in this randomized controlled clinical study. The dental elements will be extracted atraumatically, and allocated to one of the study groups (n=20/grp): Control Group (Ctl): alveolus closure with total flap elevation and simple suture; Group Free Gingival Mixed Graft (EGLM): closure of the alveolus without flap elevation, and placement of a mixed free gingival tissue graft (epithelialized in the central region and de-epithelialized (2 mm) in the vestibulolingual edges;

Bone + Mixed Free Gum Graft Group (B+EGLM): socket closure without flap elevation, placement of lyophilized bone graft and socket sealing with mixed free gingival tissue graft (as previously described);

Bone + Titanium Seal Group (B+TS): socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane. Immediately after the extractions, Cone Beam Computed Tomography (90 kVp/8 mA/2.3 sec) will be performed, with lip/cheek separation, with 1.5 mm thick slices and a 1 mm distance, with a field of vision (FOV) of 5±5 cm, which will be repeated after 6 months. During the CT scans, the patients will use intra-oral appliances with hyperdense indicators to determine the reference points to measure the variables: bone tissue height in the center of the socket (primary variable) and every 2 mm equidistantly; thickness of bone tissue in the center of the socket and every 2 mm equidistantly. Soft tissue variables will also be evaluated, such as: mucosal thickness at the height and 2 mm below the edge margin (by CT); height of the keratinized tissue (measured by a dry tip caliper). After 6 months, all patients will receive dental implants, with the ideal measurements for bone dimension, and the possibility of installing implants \>10mm or \<10mm in length will be statistically analyzed. After 4 months of dental implant placement, single prostheses will be installed and CT, soft tissue measurements and clinical parameters will be repeated (peri-implant depth; presence of biofilm and bleeding on probing; tissue thickness at the margin and 2 mm below; keratinized tissue). Implants will be re-evaluated after 12 months. All measurements will be performed by a previously calibrated examiner (intra-class correlation above 90%). The data will initially be analyzed in a descriptive way, with means and standard deviations. For comparison between groups and times, two-way/Tukey ANOVA test will be used. In all analyses, a significance level of 5% will be considered.

Eligibility criteria: Inclusion Criteria:

* Systemic health (Hypertension and Diabetes controlled)
* Indication of tooth extraction with at least 2/3 of the bone support, in the premolar or molar region
* Signing the consent form
* Individuals over 18 years of age.

Exclusion Criteria:

* Presence of periodontal disease at the time of surgery
* Pregnant and lactating women
* Smokers
* Being in orthodontic treatment
* Use medication that alters the bone healing process, such as those used to treat osteoporosis and the bisphosphonate group
* Individuals under 18 years of age

Primary outcomes:
measure: assessment of dimensional change using linear measurements through CT, evaluating bone remodeling.
timeFrame: 6 months
Secondary outcomes:
measure: evaluation of the dimensional change of soft tissues that accompany bone remodeling through linear and volume measurements in the STL
timeFrame: 6 months
measure: Visual analogy scale for pain and disconfort evaluattion which consists of a score to measure the patient's pain intensity.
timeFrame: 1 week
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Renato Casarin, PhD
role: PRINCIPAL_INVESTIGATOR
References: