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Dimensional Changes in Alveolar Ridge Preservation

R

Renato Casarin

Status

Enrolling

Conditions

Alveolar Bone Loss

Treatments

Procedure: Bone + Titanium Seal group
Procedure: Bone+ mixed free gingival graft group
Procedure: Control group
Procedure: Mixed free gingival graft group

Study type

Interventional

Funder types

Other

Identifiers

NCT06081296
59208422.8.0000.5418

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Triple Blind

80 participants in 4 patient groups

Control group
Experimental group
Description:
Alveolus closure with total flap elevation and simple suture
Treatment:
Procedure: Control group
Group Free Gingival Mixed Graft
Active Comparator group
Description:
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
Treatment:
Procedure: Mixed free gingival graft group
Bone + Mixed Free Gum Graft Group
Active Comparator group
Description:
Socket closure without flap elevation, placement of lyophilized bone graft and socket sealing with mixed free gingival tissue graft (as previously described)
Treatment:
Procedure: Bone+ mixed free gingival graft group
Bone + Titanium Seal Group
Active Comparator group
Description:
Socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane.
Treatment:
Procedure: Bone + Titanium Seal group

Trial contacts and locations

1

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Central trial contact

Leticia S Arroteia, DDS; Renato Casarin, PhD

Data sourced from clinicaltrials.gov

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