Alveolar Ridge Preservation Techniques After Tooth Extraction

Clinical Evaluation of Different Alveolar Ridge Preservation Techniques After Tooth Extraction: a Single- Center, Triple Blinded Randomized Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Other: Alveolar ridge preservation

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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Αττική
    • Athens, Αττική, Greece, 11527
      • National and Kapodistrian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alveolar ridge preservation with particulated allograft covered with collagen sponge.; 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).	Other: Alveolar ridge preservation; application of different bone graft and sealing means after tooth extraction
Experimental: Alveolar ridge preservation with particulated allograft covered with autogenous soft tissue punch; 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).	Other: Alveolar ridge preservation; application of different bone graft and sealing means after tooth extraction
Experimental: Alveolar ridge preservation with particulated xenograft covered with autogenous soft tissue punch; 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).	Other: Alveolar ridge preservation; application of different bone graft and sealing means after tooth extraction
Experimental: Alveolar ridge preservation without bone grafting covered with socket sealing mean; Alveolar ridge preservation after tooth extraction. No bone graft was applied and the socket was covered with free gingival graft (FGG).	Other: Alveolar ridge preservation; application of different bone graft and sealing means after tooth extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	4 months
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).	4 months

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): June 25, 2020

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: Ethical committe No324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No