Effectiveness of Alveolar Bone Preservation in Alveoli With Infectious Process

Effectiveness of Autologous Bone and Bioactive Glass for Alveolar Preservation in Alveoli With Infectious Process

Alveolar ridge preservation (ARP) is a surgical technique that aims to minimize the degree of dimensional changes following extraction. In the healing period after extraction, the alveolar bone (AB) undergoes morphological changes during the remodeling process. The changes become evident immediately after tooth extraction, with greater resorption changes observed during the first two months, and these dimensional changes can be observed 1 year after surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: alveolar ridge preservation with autologous bone; Procedure: alveolar ridge preservation with bioactive glass

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ecuador
  • Guayas
    • Samborondon, Guayas, Ecuador, 09-01-952
      • Universidadees
      • Contact: Antonio G Lanata, 5 level; Phone Number: +593983820084; Email: alanata@uees.edu.ec
      • Contact: Daniel L Campoverde, 3 level; Phone Number: +593984364517; Email: dcampoverdelo@uees.edu.ec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients over 18 years of age
• Patients with indicated tooth extractions
• Patients who have accepted the conditions of the study

Exclusion Criteria:

• Pregnant patients, breastfeeding or using oral contraceptives
• Smoking patients
• Patients with uncontrolled systemic diseases
• History of autoimmune disease
• Previous traumatic extraction
• Patients taking bisphosphonates or anticoagulants
• Patients who are or have undergone chemotherapy and radiotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: autologous bone; An autologous bone graft is defined as a living tissue capable of promoting bone healing by transferring that tissue from a donor area to a recipient area. It has been defined as the "gold standard" for having the capacity for osteogenesis, osteoinduction, osteoconduction and providing good structural support, showing high biocompatibility and low immunogenicity, however, autologous bone is limited and has greater morbidity due to the collection of autologous bone from the donor site, increased surgical time, greater infection, inflammation, pain and bleeding.	Procedure: alveolar ridge preservation with autologous bone; Autologous bone graft in alveolar ridge preservation.
Experimental: Bioactive glass; Bioactive glasses (VB) are a group of synthetic ceramics based on silicates coupled with other minerals. Desirable properties of VB include good biocompatibility, osteoconductivity, antimicrobial activity and a porous structure that promotes vascularization	Procedure: alveolar ridge preservation with bioactive glass; Bioactive glass grafted into alveolar preservation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate bone formation	the dimensional bone changes of the preserved at each stage of healing will be analyzed by computer tomography	The evaluation will occur from enrollment through the end of treatment at 12 months. Assessments will be conducted preoperatively, 7 days post-surgery, as well as at 3, 6, and 12 months following the surgery.

Collaborators and Investigators

• Sponsor: Universidad de Especialidades Espiritu Santo

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2024
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 15, 2029

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Bone Substitutes; Alveolar Bone Grafting; Alveolar Resorption; Alveolar process
• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss
• Other Study ID Numbers: 2024-ODONT-002C

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