Dimensional Changes in Alveolar Ridge Preservation
Dimensional Changes After Different Alveolar Ridge Preservation Techniques for Posterior Region: Randomized Controlled Trial
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 2, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedOctober 13, 2023
October 1, 2023
1.1 years
October 2, 2023
October 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
assessment of dimensional change using linear measurements through CT, evaluating bone remodeling.
Through CT taken immediately after tooth extraction and six months later, these images will be analyzed to evaluate changes in hard tissues
6 months
Secondary Outcomes (2)
evaluation of the dimensional change of soft tissues that accompany bone remodeling through linear and volume measurements in the STL
6 months
Visual analogy scale for pain and disconfort evaluattion which consists of a score to measure the patient's pain intensity.
1 week
Study Arms (4)
Control group
EXPERIMENTALAlveolus closure with total flap elevation and simple suture
Group Free Gingival Mixed Graft
ACTIVE COMPARATORClosure 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
ACTIVE COMPARATORSocket 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
ACTIVE COMPARATORSocket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane.
Interventions
Control Group (Ctl): alveolus closure with total flap elevation and simple suture; and socket sealing with mixed free gingival tissue graft.
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.
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.
socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Renato Casarinlead
Study Sites (1)
Piracicaba Dental School
Piracicaba, São Paulo, 13414903, Brazil
Related Publications (1)
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 Nov;52(11):1584-1594. doi: 10.1111/jcpe.70004. Epub 2025 Aug 5.
PMID: 40762250DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renato Casarin, PhD
University of Campinas, Brazil
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Randomization by electronically generated list; Different examiners than operator; Bliding patient;
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
October 2, 2023
First Posted
October 13, 2023
Study Start
September 1, 2022
Primary Completion
October 15, 2023
Study Completion
September 1, 2024
Last Updated
October 13, 2023
Record last verified: 2023-10