Dimensional Changes in Alveolar Ridge Preservation

October 6, 2023 updated by: Renato Casarin

Dimensional Changes After Different Alveolar Ridge Preservation Techniques for Posterior Region: Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • Piracicaba, São Paulo, Brazil, 13414903
        • Recruiting
        • Piracicaba Dental School
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control group
Alveolus closure with total flap elevation and simple suture
Procedure: Control group
Control Group (Ctl): alveolus closure with total flap elevation and simple suture; and socket sealing with mixed free gingival tissue graft.
Other Names:
  • Mixed free gingival graft group
  • Bone+ mixed free gingival graft group
  • Bone + Titanium Seal group
Active Comparator: 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
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.
Other Names:
  • Bone+ mixed free gingival graft group
  • Bone + Titanium Seal group
Active Comparator: 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)
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.
Other Names:
  • Bone + Titanium Seal group
Active Comparator: Bone + Titanium Seal Group
Socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane.
Procedure: Bone + Titanium Seal group
socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of dimensional change using linear measurements through CT, evaluating bone remodeling.
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of the dimensional change of soft tissues that accompany bone remodeling through linear and volume measurements in the STL
Time Frame: 6 months
Through STLs taken immediately after extraction and six months later, these images will be analyzed to evaluate changes in soft tissues
6 months
Visual analogy scale for pain and disconfort evaluattion which consists of a score to measure the patient's pain intensity.
Time Frame: 1 week
Will be also evaluate post-operative pain and discomfort,.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renato Casarin

Investigators

  • Principal Investigator: Renato Casarin, PhD, University of Campinas, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

October 15, 2023

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59208422.8.0000.5418

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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