Back to resultsAlveolar Ridge Preservation Techniques After Tooth Extraction
Primary Purpose
Alveolar Bone Loss
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Alveolar ridge preservation
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
Eligibility Criteria
Inclusion Criteria:
- systematically healthy patients
- non-smokers
- no use of antibiotics for the last 3 months
- presence of a non-restorable single-rooted tooth in the maxilla.
Exclusion Criteria:
- Patients were excluded when a bony wall loss of more than 50% was verified for the socket after the extraction
Sites / Locations
- National and Kapodistrian University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Alveolar ridge preservation with particulated allograft covered with collagen sponge.
Alveolar ridge preservation with particulated allograft covered with autogenous soft tissue punch
Alveolar ridge preservation with particulated xenograft covered with autogenous soft tissue punch
Alveolar ridge preservation without bone grafting covered with socket sealing mean
Arm Description
Alveolar ridge preservation after tooth extraction. Freeze-dried bone allograft (FDBA) was applied in the socket immediatelly after tooth extraction and it was covered with collagen sponge (CS).
Alveolar ridge preservation after tooth extraction. Freeze-dried bone allograft (FDBA) was applied in the socket immediatelly after tooth extraction and it was covered with free gingival graft (FGG).
Alveolar ridge preservation after tooth extraction. Demineralized bovine bone mineral xenograft (DBBM) was applied in the socket immediatelly after tooth extraction and it was covered with free gingival graft (FGG).
Alveolar ridge preservation after tooth extraction. No bone graft was applied and the socket was covered with free gingival graft (FGG).
Outcomes
Primary Outcome Measures
Vertical dimensional alterations of the alveolar ridge, after tooth extraction.
Assessment of the alteration of the alveolar ridge height after different alveolar ridge preservation techniques, based on clinical measurements. Clinical measurements were carried out immediately after tooth extraction and 4 months later. Distances in those clinical measurements were recorded in 0.1 mm increments, using a digital calliper (Logilink digital caliper WZ0031).
Horizontal dimensional alterations of the alveolar ridge, after tooth extraction.
Assessment of the alteration of the alveolar ridge width after different alveolar ridge preservation techniques, based on clinical measurements. Clinical measurements were carried out immediately after tooth extraction and 4 months later. Distances in those clinical measurements were recorded in 0.1 mm increments, using a digital calliper (Logilink digital caliper WZ0031).
Secondary Outcome Measures
Full Information
NCT ID
NCT04934813
First Posted
June 4, 2021
Last Updated
June 14, 2021
Sponsor
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT04934813
Brief Title
Alveolar Ridge Preservation Techniques After Tooth Extraction
Official Title
Clinical Evaluation of Different Alveolar Ridge Preservation Techniques After Tooth Extraction: a Single- Center, Triple Blinded Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
June 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the present randomized controlled trial (RCT) was to evaluate the efficacy of different alveolar ridge preservation (ARP) techniques on hard tissue dimensional alterations after tooth extraction, based on clinical measurements.
Detailed Description
Thrirty-six patients were randomly assigned in four treatment groups: A) freeze-dried bone allograft (FDBA) covered with collagen sponge (CS), B) FDBA covered with free gingival graft (FGG), C) demineralized bovine bone mineral xenograft (DBBM) covered with FGG and D) FGG without socket grafting. Clinical measurements were performed immediately after tooth extraction and 4 months later. The related outcomes pertained to both vertical and horizontal assessment of bone loss
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
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alveolar ridge preservation with particulated allograft covered with collagen sponge.
Arm Type
Experimental
Arm Description
Alveolar ridge preservation after tooth extraction. Freeze-dried bone allograft (FDBA) was applied in the socket immediatelly after tooth extraction and it was covered with collagen sponge (CS).
Arm Title
Alveolar ridge preservation with particulated allograft covered with autogenous soft tissue punch
Arm Type
Experimental
Arm Description
Alveolar ridge preservation after tooth extraction. Freeze-dried bone allograft (FDBA) was applied in the socket immediatelly after tooth extraction and it was covered with free gingival graft (FGG).
Arm Title
Alveolar ridge preservation with particulated xenograft covered with autogenous soft tissue punch
Arm Type
Experimental
Arm Description
Alveolar ridge preservation after tooth extraction. Demineralized bovine bone mineral xenograft (DBBM) was applied in the socket immediatelly after tooth extraction and it was covered with free gingival graft (FGG).
Arm Title
Alveolar ridge preservation without bone grafting covered with socket sealing mean
Arm Type
Experimental
Arm Description
Alveolar ridge preservation after tooth extraction. No bone graft was applied and the socket was covered with free gingival graft (FGG).
Intervention Type
Other
Intervention Name(s)
Alveolar ridge preservation
Intervention Description
application of different bone graft and sealing means after tooth extraction
Primary Outcome Measure Information:
Title
Vertical dimensional alterations of the alveolar ridge, after tooth extraction.
Description
Assessment of the alteration of the alveolar ridge height after different alveolar ridge preservation techniques, based on clinical measurements. Clinical measurements were carried out immediately after tooth extraction and 4 months later. Distances in those clinical measurements were recorded in 0.1 mm increments, using a digital calliper (Logilink digital caliper WZ0031).
Time Frame
4 months
Title
Horizontal dimensional alterations of the alveolar ridge, after tooth extraction.
Description
Assessment of the alteration of the alveolar ridge width after different alveolar ridge preservation techniques, based on clinical measurements. Clinical measurements were carried out immediately after tooth extraction and 4 months later. Distances in those clinical measurements were recorded in 0.1 mm increments, using a digital calliper (Logilink digital caliper WZ0031).
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
systematically healthy patients
non-smokers
no use of antibiotics for the last 3 months
presence of a non-restorable single-rooted tooth in the maxilla.
Exclusion Criteria:
Patients were excluded when a bony wall loss of more than 50% was verified for the socket after the extraction
Facility Information:
Facility Name
National and Kapodistrian University
City
Athens
State/Province
Αττική
ZIP/Postal Code
11527
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
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Alveolar Ridge Preservation Techniques After Tooth Extraction
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