Dental ImplantsNCT06172114
Bovine-derived Xenograft With or Without L-PRF for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled Trial
A study testing Alveolar ridge preservation using sticky bone in people with Dental Implants and Tooth Extraction, run by Mohammed Bin Rashid University of Medicine and Health Sciences.
Trial summary
The study is prospective randomized clinical trial that aims to evaluate the adjunctive use of L-PRF in promoting the desired vascularization and bone fill in small and large defects following tooth extraction and report on the long-term implant and patient outcomes Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Tooth Extraction, Bone Regeneration
- What is being tested?
- Alveolar ridge preservation using sticky bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2024to 9 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 or over.
- Require extraction of anterior or posterior single tooth due to caries, endodontic and prosthetic complications.
- The tooth that requires extraction is bordered by two teeth.
- Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).
- Good compliance and commitment to attend follow-up review appointments.
- Willing to provide informed consent.
Who cannot join
- Localised / generalised periodontitis.
- Presence of acute periapical lesion.
- Bone metabolic disease and/or taking medications that affect bone metabolism.
- Long term use of non-steroidal anti-inflammatory medications.
- History of malignancy, radiotherapy or chemotherapy.
- Pregnant or lactating women.
- Severe bruxism or parafunctional habits.
- Large occlusal discrepancies.
About this study
Official title: Bovine-derived Xenograft (Bio-Oss Collagen) With or Without Leukocyte-platelet Rich Fibrin (L-PRF) for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled Trial
The study is prospective randomized clinical trial that aims to evaluate the adjunctive use of L-PRF in promoting the desired vascularization and bone fill in small and large defects following tooth extraction and report on the long-term implant and patient outcomes
- Conditions
- Dental Implants, Tooth Extraction, Bone Regeneration
- Being tested
- Alveolar ridge preservation using sticky bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge preservation using sticky boneProcedure or surgery
In the test group the xenograft will be mixed in with the L-PRF then placed into the socket.
| Study group | Role | What they receive |
|---|---|---|
| Control group (C) | Active comparator | Xenograft + resorbable collagen membrane Receives: Procedure: Alveolar ridge preservation using sticky bone |
| Test group (T) | Experimental | Xenograft combined with L-PRF + resorbable collagen membrane Receives: Procedure: Alveolar ridge preservation using sticky bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival / success rate will be assessed clinically after one year of implant restoration and annually up to three years.
Measured: 2 years
Patient postoperative experience will be assessed using visual analogue scale during the first week following tooth extraction and ridge preservation.
Reporting a score will be done using the pain visual analogue scale. Minimum value is 0 which is no pain and maximum value is 10 which is the worst pain ever experienced.
Measured: 2 years
Secondary outcomes (5)
Changes in width and height of alveolar ridge will be assessed at the time of tooth extraction and ridge preservation, six months (prior to implant placement) and annually up to two years using cone beam computed tomography (CBCT).
Measured: 2 years
Need for additional bone augmentation will only be assessed at the time of implant placement by recording the use of bone graft (if required) in the clinical notes.
Measured: 2 years
Changes in peri-implant marginal bone level will be assessed at implant placement (baseline) and after one year of implant restoration and annually up to two years using standardized peri-apical radiograph.
Measured: 2 years
Soft tissue levels (midbuccal marginal tissue level changes, interproximal papilla level changes and changes in width of keratinised tissue) will be assessed at implant placement (baseline), at 1 year and at 2 years
Measured: 2 years
Biological complications (i.e. peri-implant diseases) will be assessed clinically using periodontal probe after one year of implant restoration and annually up to two years.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start20 Apr 2024 (estimated)
- Primary completion9 Dec 2025 (estimated)
- Study completion9 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Hakam, Mohammed Bin Rashid University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172114
- Sponsor's protocol ID
- MBRU-PRF
- Status last verified
- Mar 2024
- First submitted
- 22 Nov 2023
- Last updated
- 13 Mar 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bovine-derived Xenograft (Bio-Oss Collagen) With or Without Leukocyte-platelet Rich Fibrin (L-PRF) for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06172114
- Acronym / sponsor ID
- MBRU-PRF
- Conditions
- Dental Implants, Tooth Extraction, Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health SciencesUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 9 Dec 2025 (estimated)
- Study completion
- 9 Dec 2025 (estimated)
- First posted
- 15 Dec 2023 (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 study is prospective randomized clinical trial that aims to evaluate the adjunctive use of L-PRF in promoting the desired vascularization and bone fill in small and large defects following tooth extraction and report on the long-term implant and patient outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (C) | Active comparator | Procedure: Alveolar ridge preservation using sticky boneXenograft + resorbable collagen membrane |
| Test group (T) | Experimental | Procedure: Alveolar ridge preservation using sticky boneXenograft combined with L-PRF + resorbable collagen membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 or over.
- Require extraction of anterior or posterior single tooth due to caries, endodontic and prosthetic complications.
- The tooth that requires extraction is bordered by two teeth.
- Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).
- Good compliance and commitment to attend follow-up review appointments.
Key exclusion criteria (8 listed)
- Localised / generalised periodontitis.
- Presence of acute periapical lesion.
- Bone metabolic disease and/or taking medications that affect bone metabolism.
- Long term use of non-steroidal anti-inflammatory medications.
- History of malignancy, radiotherapy or chemotherapy.
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 using sticky boneIn the test group the xenograft will be mixed in with the L-PRF then placed into the socket. | Procedure or surgery | Control group (C), Test group (T) |
Primary outcome
Implant survival / success rate will be assessed clinically after one year of implant restoration and annually up to three years.
Time frame: 2 years
Patient postoperative experience will be assessed using visual analogue scale during the first week following tooth extraction and ridge preservation.
Time frame: 2 years
Reporting a score will be done using the pain visual analogue scale. Minimum value is 0 which is no pain and maximum value is 10 which is the worst pain ever experienced.
5 secondary outcomes
Changes in width and height of alveolar ridge will be assessed at the time of tooth extraction and ridge preservation, six months (prior to implant placement) and annually up to two years using cone beam computed tomography (CBCT).
Time frame: 2 years
Need for additional bone augmentation will only be assessed at the time of implant placement by recording the use of bone graft (if required) in the clinical notes.
Time frame: 2 years
Changes in peri-implant marginal bone level will be assessed at implant placement (baseline) and after one year of implant restoration and annually up to two years using standardized peri-apical radiograph.
Time frame: 2 years
Soft tissue levels (midbuccal marginal tissue level changes, interproximal papilla level changes and changes in width of keratinised tissue) will be assessed at implant placement (baseline), at 1 year and at 2 years
Time frame: 2 years
Biological complications (i.e. peri-implant diseases) will be assessed clinically using periodontal probe after one year of implant restoration and annually up to two years.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 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. 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 Alveolar ridge preservation using sticky bone in people with Dental Implants and Tooth Extraction, run by Mohammed Bin Rashid University of Medicine and Health Sciences.
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 8 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. 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?
Results are not available in the source record.
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?
Implant survival / success rate will be assessed clinically after one year of implant restoration and annually up to three years. (time frame: 2 years). 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 13 Mar 2024.