Alveolar Bone LossNCT05183386
Histological Outcome of the Use of Different Biomaterials for Fresh Socket Regeneration. A Split-mouth Design
A study testing dental socket regeneration in people with Alveolar Bone Loss, run by University of Salamanca.
Trial summary
Purpose: The aim of this study was to analyze the quality of bone regeneration in fresh sockets using four different materials and at different times points. Materials and Methods: A split-mouth clinical trial was designed to evaluate the histological and histomorphometrical characteristics of fresh sockets from 30… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- dental socket regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in need of at least one bilateral tooth extraction due to one or more of the following causes:
- periodontal disease,
- vertical fracture
- included teeth.
- Patients seeking dental implant to replace their missing teeth.
- All sockets should have intact or partially conserved buccal wall according to Elian´s classification (Type I, II).
Who cannot join
- Patients under 18 years old.
- Patients with a severely untreated periodontal disease.
- Smokers of more than 15 cigarettes a day.
- patients suffering from any systemic disease requiring pharmacological treatment.
- Patients whose socket´s buccal wall is totally missing after tooth extraction
About this study
Official title: Histological Outcome of the Use of Different Biomaterials for Fresh Socket. A Split Mouth Design
Purpose: The aim of this study was to analyze the quality of bone regeneration in fresh sockets using four different materials and at different times points.
Materials and Methods: A split-mouth clinical trial was designed to evaluate the histological and histomorphometrical characteristics of fresh sockets from 30 patients. One socket per patient will healed spontaneously (control) and, at least, one fresh socket, will be grafted with platelet-rich growth factor (PRGF), PRGF+autologous bone, autologous bone or PRGF+demineralized freeze dried bone allograft (DFDBA). The day of the implant placement, biopsies will be taken at different time points divided into three assessment groups: short duration (2-4 months), intermediate duration (5-6 months) and long duration (7-12 months). The histologic findings will be assessed to quantify the trabeculae pattern, the degree of mineralization and the quality of bone regeneration.
- Conditions
- Alveolar Bone Loss
- Being tested
- dental socket regeneration
- 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.
dental socket regenerationProcedure or surgery
after a dental extraction the fresh socket is filled with graft materials and compared with the spontaneous healing (control)
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The dental socket heals spontaneously |
| Experimental group | Experimental | Distinct bone graft regeneration strategies (PRGF, Autologous bone and DFDBA) Receives: Procedure: dental socket regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of mineralization
Histological Assessment by Von Kossa Stain of the degree of the mineralization in the regenerated bone inside the alveolar walls
Measured: 2-12 months
type of bone maturation
Histological Assessment by Goldner Trichromic Stain of the grade of maturation in the regenerated bone inside the alveolar walls
Measured: 2-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Jan 2014
- Primary completion1 Jan 2019
- Study completion1 Jan 2020
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAVIER MONTERO, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183386
- Sponsor's protocol ID
- SocketRegenerationExp
- Status last verified
- Jan 2022
- First submitted
- 20 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Outcome of the Use of Different Biomaterials for Fresh Socket. A Split Mouth Design
- ClinicalTrials.gov ID
- NCT05183386
- Acronym / sponsor ID
- SocketRegenerationExp
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 10 Jan 2022 (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.
Purpose: The aim of this study was to analyze the quality of bone regeneration in fresh sockets using four different materials and at different times points.
Materials and Methods: A split-mouth clinical trial was designed to evaluate the histological and histomorphometrical characteristics of fresh sockets from 30 patients. One socket per patient will healed spontaneously (control) and, at least, one fresh socket, will be grafted with platelet-rich growth factor (PRGF), PRGF+autologous bone, autologous bone or PRGF+demineralized freeze dried bone allograft (DFDBA). The day of the implant placement, biopsies will be taken at different time points divided into three assessment groups: short duration (2-4 months), intermediate duration (5-6 months) and long duration (7-12 months). The histologic findings will be assessed to quantify the trabeculae pattern, the degree of mineralization and the quality of bone regeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The dental socket heals spontaneously |
| Experimental group | Experimental | Procedure: dental socket regenerationDistinct bone graft regeneration strategies (PRGF, Autologous bone and DFDBA) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients in need of at least one bilateral tooth extraction due to one or more of the following causes:
- Patients seeking dental implant to replace their missing teeth.
- All sockets should have intact or partially conserved buccal wall according to Elian´s classification (Type I, II).
Key exclusion criteria (5 listed)
- Patients under 18 years old.
- Patients with a severely untreated periodontal disease.
- Smokers of more than 15 cigarettes a day.
- patients suffering from any systemic disease requiring pharmacological treatment.
- Patients whose socket´s buccal wall is totally missing after tooth 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 |
|---|---|---|
| dental socket regenerationafter a dental extraction the fresh socket is filled with graft materials and compared with the spontaneous healing (control) | Procedure or surgery | Experimental group |
Primary outcome
Degree of mineralization
Time frame: 2-12 months
Histological Assessment by Von Kossa Stain of the degree of the mineralization in the regenerated bone inside the alveolar walls
type of bone maturation
Time frame: 2-12 months
Histological Assessment by Goldner Trichromic Stain of the grade of maturation in the regenerated bone inside the alveolar walls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing dental socket regeneration in people with Alveolar Bone Loss, run by University of Salamanca.
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 5 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: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of mineralization (time frame: 2-12 months). The study lists 2 primary outcomes in all. 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 11 Jan 2022.