Hopeless ToothNCT06698276
Performance of Next-X in Alveolar Ridge Preservation
A study testing Alveolar Ridge Reconstruction in people with Hopeless Tooth, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The goal of this case series study is to evaluate the clinical and histological outcomes of a protocol for managing hopeless teeth, focusing on alveolar preservation and subsequent dental implant placement. The study will also assess the long-term success of prosthetic reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hopeless Tooth
- What is being tested?
- Alveolar Ridge Reconstruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2024to 1 Dec 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 18 and 80 years of age.
- 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.
Who cannot join
- All smokers, including smoking alternatives.
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Faculdade de Odontologia da USP
São Paulo, São Paulo, 05508-000
Igor S Medeiros, +551130910062, igorsm@usp.br
Graziela F Malagutti, +5511309167817, dirfo@usp.br
About this study
Official title: Clinical and Histological Assessment of a Bone Substitute Enriched With Bioactive Glass for Ridge Preservation
The goal of this case series study is to evaluate the clinical and histological outcomes of a protocol for managing hopeless teeth, focusing on alveolar preservation and subsequent dental implant placement. The study will also assess the long-term success of prosthetic reconstruction. The main questions it aims to answer are:
- 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?
Read more
Participants will:
- Undergo extraction of hopeless teeth using an atraumatic protocol.
- Receive alveolar preservation treatment with biomaterials immediately after extraction.
- Provide a bone biopsy for histological processing before implant placement.
- Undergo dental implant placement and prosthetic reconstruction of the lost tooth.
- Attend follow-up appointments over a 1-year period for clinical and radiographic evaluations.
- Conditions
- Hopeless Tooth
- Being tested
- Alveolar Ridge Reconstruction
- Keywords
- prospective case series
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar Ridge ReconstructionOther
It will be used a combination of two biomaterials for alveolar ridge preservation
| Study group | Role | What they receive |
|---|---|---|
| 2 months reopen group | Experimental | a biomaterial will be used to alveolar ridge preservation, and after 2 months participants of this group will receive a dental implant Receives: Other: Alveolar Ridge Reconstruction |
| 3 months reopen group | Experimental | a biomaterial will be used to alveolar ridge preservation, and after 3 months participants of this group will receive a dental implant Receives: Other: Alveolar Ridge Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
histological analysis
Histological sections will be stained with hematoxylin-eosin (HE) and Masson's trichrome. A semi-quantitative analysis will be performed by a pathologist (Blinded for the groups), adopting a histological score system (0 - absence, 1- mild; 2 - mild to moderate, 3 - moderate to intense, and 4 - intense). These scores will be determined based on the intensity of the following histological parameters: necrosis, inflammatory infiltrate, fibrosis, biomaterial remnants, new-formed bone trabeculae, and angiogenesis. A histomorphometric analysis will also be performed for the trabecular bone area, cellularity area, and microvessel density.
Measured: Samples will be collected at 2 and 3 months after the surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Dec 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hopeless ToothStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Alexandre Romito, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698276
- Sponsor's protocol ID
- Next-X
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data can not be shared without he/she approval.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Assessment of a Bone Substitute Enriched With Bioactive Glass for Ridge Preservation
- ClinicalTrials.gov ID
- NCT06698276
- Acronym / sponsor ID
- Next-X
- Conditions
- Hopeless Tooth
- Keywords
- prospective case series
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Nov 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.
The goal of this case series study is to evaluate the clinical and histological outcomes of a protocol for managing hopeless teeth, focusing on alveolar preservation and subsequent dental implant placement. The study will also assess the long-term success of prosthetic reconstruction. The main questions it aims to answer are:
- 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:
- Undergo extraction of hopeless teeth using an atraumatic protocol.
- Receive alveolar preservation treatment with biomaterials immediately after extraction.
- Provide a bone biopsy for histological processing before implant placement.
- Undergo dental implant placement and prosthetic reconstruction of the lost tooth.
- Attend follow-up appointments over a 1-year period for clinical and radiographic evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 months reopen group | Experimental | Other: Alveolar Ridge Reconstructiona biomaterial will be used to alveolar ridge preservation, and after 2 months participants of this group will receive a dental implant |
| 3 months reopen group | Experimental | Other: Alveolar Ridge Reconstructiona biomaterial will be used to alveolar ridge preservation, and after 3 months participants of this group will receive a dental implant |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults between 18 and 80 years of age.
- 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.
Key exclusion criteria (15 listed)
- All smokers, including smoking alternatives.
- 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.
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 ReconstructionIt will be used a combination of two biomaterials for alveolar ridge preservation | Other | 2 months reopen group, 3 months reopen group |
Primary outcome
histological analysis
Time frame: Samples will be collected at 2 and 3 months after the surgical intervention
Histological sections will be stained with hematoxylin-eosin (HE) and Masson's trichrome. A semi-quantitative analysis will be performed by a pathologist (Blinded for the groups), adopting a histological score system (0 - absence, 1- mild; 2 - mild to moderate, 3 - moderate to intense, and 4 - intense). These scores will be determined based on the intensity of the following histological parameters: necrosis, inflammatory infiltrate, fibrosis, biomaterial remnants, new-formed bone trabeculae, and angiogenesis. A histomorphometric analysis will also be performed for the trabecular bone area, cellularity area, and microvessel density.
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 6 Dec 2024.
- Individual participant dataSharing planned: Undecided. Individual participant data can not be shared without he/she approval.
Related trials for Hopeless Tooth
Enrolling by invitation
Peri-implant Tissue Changes Using Dual Zone Concept With Connective Tissue Graft Versus Concentrated Growth Factor
Hopeless Tooth in Esthetic Zone, Loss of Soft and Hard Tissue Around Implant
Active, not recruiting
Comparison of Replantation and Splinting Alone in Lower Anterior Teeth
Periodontitis
Recruiting
To Compare Post-Extraction Use of a Novel Ethylenediaminetetraacetic Acid (EDTA) Post-operative Mouth Rinse and Daily Use EDTA Mouth Rinse and Standard 0.12% Chlorhexidine (CHX) Post-operative Mouth Rinse and Daily Use Essential Oil (EO) Mouth Rinse.
Extraction Sites After Removal and Bone Replacement Grafting at Extraction Sockets of Dentally Hopeless Single-rooted Teeth
Enrolling by invitation
Immediate Dental Implant Installation With and Without Socket Shield Technique in Aesthetic Zone
Immediate Dental Implants, Thin Labial Plate of Bone Pre-extraction
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 Reconstruction in people with Hopeless Tooth, run by University of Sao Paulo at 1 site in Brazil.
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 6 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 6 Dec 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 Brazil. 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?
Contact Giuseppe A Romito (+551130917833, garomito@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histological analysis (time frame: Samples will be collected at 2 and 3 months after the surgical intervention). 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 6 Dec 2024.