ClinicalTrials.gg
Not yet recruitingNCT06661863Updated Oct 28, 2024

Effectiveness of Alveolar Bone Preservation in Alveoli With Infectious Process

An interventional study of alveolar ridge preservation with bioactive glass and alveolar ridge preservation with autologous bone in Alveolar Bone Loss, sponsored by Universidad de Especialidades Espiritu Santo. Not yet recruiting at 1 site in Ecuador. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by Universidad de Especialidades Espiritu Santo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Alveolar Bone Loss

Browse trials for

Keywords

  • Alveolar Resorption
  • Alveolar process
  • Bone Substitutes
  • Alveolar Bone Grafting
03

In context

Alveolar Bone Loss

318 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.

This study's planned enrollment of 28 is above the median of 25 across 269 interventional studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

Universidad de Especialidades Espiritu Santo is the lead sponsor of 10 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant patients, breastfeeding or using oral
  • Smoking patients
  • Patients with uncontrolled systemic diseases
  • History of disease
  • Previous traumatic extraction
  • Patients taking bisphosphonates or anticoagulants
  • Patients who are or have undergone chemotherapy and radiotherapy
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
28 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Procedurealveolar ridge preservation with bioactive glass

    Bioactive glass grafted into alveolar preservation.

  • Procedurealveolar ridge preservation with autologous bone

    Autologous bone graft in alveolar ridge preservation.

06

What researchers measure

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

    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.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2024; primary completion for Dec 2024, 1 month later.

Of 167 non-industry interventional studies with no phase under Alveolar Bone Loss, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 1 month is below that.

Counting every sponsor, half of 167 studies reached it within 18 months; a quarter within 11 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2024
First posted
Oct 28, 2024
StartEst.
Nov 15, 2024
Primary completionEst.
Dec 15, 2024
CompletionEst.
Dec 15, 2029
Last update
Oct 28, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06661863
Lead sponsor
Universidad de Especialidades Espiritu Santo
Responsible party
Antonio Lanata Flores (Assistant Professor, Universidad de Especialidades Espiritu Santo) — Principal investigator
First posted
Oct 28, 2024
Start date
Nov 15, 2024 (estimated)
Primary completion
Dec 15, 2024 (estimated)
Completion
Dec 15, 2029 (estimated)
Last update
Oct 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion