Effectiveness of Alveolar Bone Preservation in Alveoli With Infectious Process

NCT06661863 | Not Yet Recruiting

• 1 other identifier: 2024-ODONT-002C
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alveolar Bone Loss

Keywords

Alveolar Resorption; Alveolar process; Bone Substitutes; Alveolar Bone Grafting

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

autologous bone

ACTIVE COMPARATOR

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

Bioactive glass

EXPERIMENTAL

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

Interventions

alveolar ridge preservation with bioactive glass PROCEDURE

Bioactive glass grafted into alveolar preservation.

Bioactive glass

alveolar ridge preservation with autologous bone PROCEDURE

Autologous bone graft in alveolar ridge preservation.

autologous bone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Especialidades Espiritu Santo: lead

Study Sites (1)

Universidadees

Samborondón, Guayas, 09-01-952, Ecuador

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not know wich biomaterial will be grafted
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study includes 28 patients who have a tooth extraction indicated in reference to g. avila-ortiz et al. 2020. They will be divided into 2 randomized groups, 14 sockets with an infectious process will be preserved with autologous bone and the remaining 14 with 58s bioactive glass

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: October 28, 2024
• Study Start: November 15, 2024
• Primary Completion: December 15, 2024
• Study Completion (Estimated): December 15, 2029
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)