Study Results
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Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2022-09-01
2024-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Control group
Alveolus closure with total flap elevation and simple suture
Control group
Control Group (Ctl): alveolus closure with total flap elevation and simple suture; and socket sealing with mixed free gingival tissue graft.
Group Free Gingival Mixed Graft
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
Mixed free gingival graft group
closure of the alveolus without flap elevation, and placement of a free gingival tissue graft removed from the individual's own palate, which will be properly sutured. This graft is a combination of epithelialized-subepithelial connective tissue graft, which will be taken from the hard palate of the regions.
Bone + Mixed Free Gum Graft Group
Socket closure without flap elevation, placement of lyophilized bone graft and socket sealing with mixed free gingival tissue graft (as previously described)
Bone+ mixed free gingival graft group
closure of the socket without flap elevation, placement of a freeze-dried bone graft and sealing of the socket with a mixed free gingival tissue graft.
Bone + Titanium Seal Group
Socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane.
Bone + Titanium Seal group
socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane.
Interventions
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Control group
Control Group (Ctl): alveolus closure with total flap elevation and simple suture; and socket sealing with mixed free gingival tissue graft.
Mixed free gingival graft group
closure of the alveolus without flap elevation, and placement of a free gingival tissue graft removed from the individual's own palate, which will be properly sutured. This graft is a combination of epithelialized-subepithelial connective tissue graft, which will be taken from the hard palate of the regions.
Bone+ mixed free gingival graft group
closure of the socket without flap elevation, placement of a freeze-dried bone graft and sealing of the socket with a mixed free gingival tissue graft.
Bone + Titanium Seal group
socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Renato Casarin
OTHER
Responsible Party
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Renato Casarin
Associated Professor
Principal Investigators
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Renato Casarin, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Campinas, Brazil
Locations
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Piracicaba Dental School
Piracicaba, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Sandoli Arroteia L, Lopes MP, Rea MT, Vieira E Oliveira TR, Oliveira ML, de Faveri M, Santamaria MP, Queiroz LA, Casati MZ, Casarin RCV. Dimensional Changes After Different Alveolar Ridge Preservation Techniques for Posterior Region: A Randomised Controlled Clinical Trial. J Clin Periodontol. 2025 Aug 5. doi: 10.1111/jcpe.70004. Online ahead of print.
Other Identifiers
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59208422.8.0000.5418
Identifier Type: -
Identifier Source: org_study_id
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