search
Back to results

Dimensional Changes in Alveolar Ridge Preservation

Primary Purpose

Alveolar Bone Loss

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Control group
Mixed free gingival graft group
Bone+ mixed free gingival graft group
Bone + Titanium Seal group
Sponsored by
Renato Casarin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Piracicaba Dental SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control group

Group Free Gingival Mixed Graft

Bone + Mixed Free Gum Graft Group

Bone + Titanium Seal Group

Arm Description

Alveolus closure with total flap elevation and simple suture

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

Socket closure without flap elevation, placement of lyophilized bone graft and socket sealing with mixed free gingival tissue graft (as previously described)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 2, 2023
Last Updated
October 6, 2023
Sponsor
Renato Casarin
search

1. Study Identification

Unique Protocol Identification Number
NCT06081296
Brief Title
Dimensional Changes in Alveolar Ridge Preservation
Official Title
Dimensional Changes After Different Alveolar Ridge Preservation Techniques for Posterior Region: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Renato Casarin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Randomized Clinical Trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Randomization by electronically generated list; Different examiners than operator; Bliding patient;
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
Alveolus closure with total flap elevation and simple suture
Arm Title
Group Free Gingival Mixed Graft
Arm Type
Active Comparator
Arm 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
Arm Title
Bone + Mixed Free Gum Graft Group
Arm Type
Active Comparator
Arm Description
Socket closure without flap elevation, placement of lyophilized bone graft and socket sealing with mixed free gingival tissue graft (as previously described)
Arm Title
Bone + Titanium Seal Group
Arm Type
Active Comparator
Arm Description
Socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane.
Intervention Type
Procedure
Intervention Name(s)
Control group
Other Intervention Name(s)
Mixed free gingival graft group, Bone+ mixed free gingival graft group, Bone + Titanium Seal group
Intervention Description
Control Group (Ctl): alveolus closure with total flap elevation and simple suture; and socket sealing with mixed free gingival tissue graft.
Intervention Type
Procedure
Intervention Name(s)
Mixed free gingival graft group
Other Intervention Name(s)
Bone+ mixed free gingival graft group, Bone + Titanium Seal group
Intervention Description
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
Intervention Name(s)
Bone+ mixed free gingival graft group
Other Intervention Name(s)
Bone + Titanium Seal group
Intervention Description
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
Intervention Name(s)
Bone + Titanium Seal group
Intervention Description
socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane.
Primary Outcome Measure Information:
Title
assessment of dimensional change using linear measurements through CT, evaluating bone remodeling.
Description
Through CT taken immediately after tooth extraction and six months later, these images will be analyzed to evaluate changes in hard tissues
Time Frame
6 months
Secondary Outcome Measure Information:
Title
evaluation of the dimensional change of soft tissues that accompany bone remodeling through linear and volume measurements in the STL
Description
Through STLs taken immediately after extraction and six months later, these images will be analyzed to evaluate changes in soft tissues
Time Frame
6 months
Title
Visual analogy scale for pain and disconfort evaluattion which consists of a score to measure the patient's pain intensity.
Description
Will be also evaluate post-operative pain and discomfort,.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renato Casarin, PhD
Phone
+55 (19) 2106-5220
Email
casarinrcv@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Leticia S Arroteia, DDS
Phone
+55 (14) 981600821
Email
leticia.sandoli@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato Casarin, PhD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piracicaba Dental School
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13414903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renato Casarin, PhD
Phone
(19) 2106-5220
Email
casarinrcv@yahoo.com.br

12. IPD Sharing Statement

Learn more about this trial

Dimensional Changes in Alveolar Ridge Preservation

We'll reach out to this number within 24 hrs