Effectiveness of Alveolar Bone Preservation in Alveoli With Infectious Process

NCT ID: NCT06661863

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2029-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

alveolar ridge preservation with autologous bone

Intervention Type: PROCEDURE

Autologous bone graft in alveolar ridge preservation.

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

Group Type: EXPERIMENTAL

alveolar ridge preservation with bioactive glass

Intervention Type: PROCEDURE

Bioactive glass grafted into alveolar preservation.

Interventions

alveolar ridge preservation with bioactive glass

Bioactive glass grafted into alveolar preservation.

Intervention Type: PROCEDURE

alveolar ridge preservation with autologous bone

Autologous bone graft in alveolar ridge preservation.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Especialidades Espiritu Santo

OTHER

Sponsor Role: lead

Responsible Party

Antonio Lanata Flores

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidadees

Samborondón, Guayas, Ecuador

Countries

Ecuador

Facility Contacts

Antonio G Lanata, 5 level

Role: primary

alanata@uees.edu.ec

+593983820084

Daniel L Campoverde, 3 level

Role: backup

dcampoverdelo@uees.edu.ec

+593984364517

Other Identifiers

2024-ODONT-002C

Identifier Type: -

Identifier Source: org_study_id