Alveolar Bone LossNCT06661863
Effectiveness of Alveolar Bone Preservation in Alveoli With Infectious Process
A study testing alveolar ridge preservation with bioactive glass and alveolar ridge preservation with autologous bone in people with Alveolar Bone Loss, run by Universidad de Especialidades Espiritu Santo at 1 site in Ecuador.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- alveolar ridge preservation with bioactive glass and alveolar ridge preservation with autologous bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEcuador
- Study dates
- 15 Nov 2024to 15 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Patients with indicated tooth extractions
- Patients who have accepted the conditions of the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ecuador1 site
Universidadees
Samborondón, Guayas, 09-01-952
Antonio G Lanata, 5 level, +593983820084, alanata@uees.edu.ec
Daniel L Campoverde, 3 level, +593984364517, dcampoverdelo@uees.edu.ec
About this study
Official title: 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.
- Conditions
- Alveolar Bone Loss
- Being tested
- alveolar ridge preservation with bioactive glass, alveolar ridge preservation with autologous bone
- Keywords
- Alveolar Resorption, Alveolar process, Bone Substitutes, Alveolar Bone Grafting
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar ridge preservation with bioactive glassProcedure or surgery
Bioactive glass grafted into alveolar preservation.
alveolar ridge preservation with autologous boneProcedure or surgery
Autologous bone graft in alveolar ridge preservation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: alveolar ridge preservation with bioactive glass |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate bone formation
the dimensional bone changes of the preserved at each stage of healing will be analyzed by computer tomography
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Especialidades Espiritu Santo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Lanata Flores, Universidad de Especialidades Espiritu Santo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661863
- Sponsor's protocol ID
- 2024-ODONT-002C
- Status last verified
- Oct 2024
- First submitted
- 3 Sep 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Autologous Bone and Bioactive Glass for Alveolar Preservation in Alveoli With Infectious Process
- ClinicalTrials.gov ID
- NCT06661863
- Acronym / sponsor ID
- 2024-ODONT-002C
- Conditions
- Alveolar Bone Loss
- Keywords
- Alveolar Resorption, Alveolar process, Bone Substitutes, Alveolar Bone Grafting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Universidad de Especialidades Espiritu SantoUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| autologous bone | Active comparator | Procedure: alveolar ridge preservation with autologous boneAn 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. |
| Bioactive glass | Experimental | Procedure: alveolar ridge preservation with bioactive glassBioactive 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- Patients with indicated tooth extractions
- Patients who have accepted the conditions of the study
Key exclusion criteria (7 listed)
- Pregnant patients, breastfeeding or using oral contraceptives
- Smoking patients
- Patients with uncontrolled systemic diseases
- History of autoimmune disease
- Previous traumatic extraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alveolar ridge preservation with bioactive glassBioactive glass grafted into alveolar preservation. | Procedure or surgery | Bioactive glass |
| alveolar ridge preservation with autologous boneAutologous bone graft in alveolar ridge preservation. | Procedure or surgery | autologous bone |
Primary outcome
To evaluate bone formation
Time frame: 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.
the dimensional bone changes of the preserved at each stage of healing will be analyzed by computer tomography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alveolar ridge preservation with bioactive glass and alveolar ridge preservation with autologous bone in people with Alveolar Bone Loss, run by Universidad de Especialidades Espiritu Santo at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate bone formation (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.