Dimensional Changes in Alveolar Ridge Preservation

NCT ID: NCT06081296

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-09-01

Brief Summary

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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

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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.

Conditions

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Alveolar Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Randomized Clinical Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Randomization by electronically generated list; Different examiners than operator; Bliding patient;

Study Groups

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Control group

Alveolus closure with total flap elevation and simple suture

Group Type EXPERIMENTAL

Control group

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Mixed free gingival graft group

Intervention Type PROCEDURE

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)

Group Type ACTIVE_COMPARATOR

Bone+ mixed free gingival graft group

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Bone + Titanium Seal group

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Bone + Titanium Seal group

socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane.

Intervention Type PROCEDURE

Other Intervention Names

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Mixed free gingival graft group Bone+ mixed free gingival graft group Bone + Titanium Seal group Bone+ mixed free gingival graft group Bone + Titanium Seal group Bone + Titanium Seal group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Renato Casarin

OTHER

Sponsor Role lead

Responsible Party

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Renato Casarin

Associated Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Renato Casarin, PhD

Role: CONTACT

+55 (19) 2106-5220

Leticia S Arroteia, DDS

Role: CONTACT

+55 (14) 981600821

Facility Contacts

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Renato Casarin, PhD

Role: primary

(19) 2106-5220

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.

Reference Type DERIVED
PMID: 40762250 (View on PubMed)

Other Identifiers

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59208422.8.0000.5418

Identifier Type: -

Identifier Source: org_study_id

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