Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-12-01
2025-12-01
Brief Summary
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* How effective is the use of biomaterials for alveolar preservation in maintaining bone structure and quality?
* What are the histological characteristics of the alveolar bone after biomaterial application?
* How successful are dental implants and prosthetic reconstructions in restored sites over a 1-year follow-up period?
Participants will:
1. Undergo extraction of hopeless teeth using an atraumatic protocol.
2. Receive alveolar preservation treatment with biomaterials immediately after extraction.
3. Provide a bone biopsy for histological processing before implant placement.
4. Undergo dental implant placement and prosthetic reconstruction of the lost tooth.
5. Attend follow-up appointments over a 1-year period for clinical and radiographic evaluations.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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2 months reopen group
a biomaterial will be used to alveolar ridge preservation, and after 2 months participants of this group will receive a dental implant
Alveolar Ridge Reconstruction
It will be used a combination of two biomaterials for alveolar ridge preservation
3 months reopen group
a biomaterial will be used to alveolar ridge preservation, and after 3 months participants of this group will receive a dental implant
Alveolar Ridge Reconstruction
It will be used a combination of two biomaterials for alveolar ridge preservation
Interventions
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Alveolar Ridge Reconstruction
It will be used a combination of two biomaterials for alveolar ridge preservation
Eligibility Criteria
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Inclusion Criteria
* Requirement for single-rooted tooth extraction due to reasons such as caries, fractures, restorative issues, endodontic complications (e.g., root fracture, instrument fracture), orthodontic needs, or prosthetic considerations.
* Presence of at least one neighboring tooth adjacent to the extraction site.
* Maintaining adequate oral hygiene, indicated by bleeding on probing \<20% and plaque index \<20%.
* Presence of at least 50% of the buccal bone plate.
* Classification of patients as ASA I or II status according to the American Society of Anesthesiologists Classification.
Exclusion Criteria
* Heavy drinker (\> 60 g of alcohol per day as a mean).
* Uncontrolled metabolic disorders e.g., diabetes mellitus, osteomalacia, thyroid disorder, severe renal or hepatic disorder.
* Prolonged corticosteroid therapy.
* Immunological impairment diseases.
* History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years.
* General contraindications for dental and/or surgical treatment (including patients who take anticoagulants or antiresorptives).
* Disease or condition affecting bone metabolism.
* Women of child-bearing age, not using a highly effective method of birth control.
* Pregnancy or breast feeding.
* Previous and concurrent medication affecting sinus healing in general (e.g., topical steroids, large doses of anti-inflammatory drugs).
* Acute or chronic oral infection or uncontrolled periodontal disease.
* Crestal bone defects at the implantation site, which require additional bone augmentation around the neck of the implant.
* Allergy to collagen.
* Participation in an investigational device or drug clinical trial within the last six month.
18 Years
80 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Giuseppe Alexandre Romito
Chairman of Periodontics Division
Locations
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Faculdade de Odontologia da USP
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Igor S Medeiros
Role: primary
Graziela F Malagutti
Role: backup
Other Identifiers
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Next-X
Identifier Type: -
Identifier Source: org_study_id