Edentulous JawPRFNCT04429373
Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth
A study testing Implant installation with PRF membrane and Implant installation without PRF membrane in people with Edentulous Jaw and Dental Implant Failed, run by University of Chile at 1 site in Chile.
Trial summary
Implant retained overdentures are a cost-effective treatment for elderly patients suffering from complete tooth loss. Despite the high success rate of implants in the general population, older adults lacking all teeth are a challenging population for implant therapy, often presenting limited bone disponibility, narrow… Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw, Dental Implant Failed
- What is being tested?
- Implant installation with PRF membrane and Implant installation without PRF membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 30 Nov 2020to 20 Dec 2022
- 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 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mandibular edentulous
- > 60 years old
Who cannot join
- physical or psychological impediment for dental surgery
- dental extraction < 6 months in the mandible
- anticoagulant treatment
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
San Camilo Hospital
San Felipe, Aconcagua, 969696
Patricio Neira, DDS, (34) 249 3200, patricioneiraguerra@gmail.com
Marcelo Tejedor, DDS, (34) 249 3200, marcelo.tejedor@gmail.com
About this study
Implant retained overdentures are a cost-effective treatment for elderly patients suffering from complete tooth loss. Despite the high success rate of implants in the general population, older adults lacking all teeth are a challenging population for implant therapy, often presenting limited bone disponibility, narrow alveolar ridges, diminished bone density, scarce inserted gingiva and several co-morbidities.Thus, improving their possibility of success in implant therapy avoiding further surgical interventions is key.
Platelet-rich fibrin (PRF) is a blood derivate that can be easily and economically obtained from patients and that has shown promise of reducing the complications and improving the success of implant therapy, nevertheless its benefits in patients receiving implant retained overdentures has not been stablished. It is possible that PRF can improve the results and diminish the complications of implant therapy in older adults.
The investigation aims to demonstrate that the use of platelet-rich fibirn (PRF) is safe and beneficial for implant treatment in older adults suffering from complete tooth loss.
Read the detailed description
The investigators will conduct a split-mouth design randomized clinical trial assessing the effect of PRF in primary stability and bone/soft tissue healing around mandibular implants in edentulous elderly adults.
Aim and purpose
- To assess the effect of PRF on primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).
- To evaluate the effect of PRF on clinical parameters related to soft tissue healing, post-surgical pain/inflammation and early complications of mandibular implants in edentulous patients.
- To examine soft tissues volumetric changes pre and post- surgery using intraoral scans and bone changes using cone-beam computed tomography (CBCT) around mandibular implants in edentulous patients.
- Conditions
- Edentulous Jaw, Dental Implant Failed
- Being tested
- Implant installation with PRF membrane, Implant installation without PRF membrane
- Keywords
- dental implants, platelet-rich plasm, edentulous jaw
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant installation with PRF membraneProcedure or surgery
Platelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation
Implant installation without PRF membraneProcedure or surgery
Implant installation contralateral to the experimental side without PRF membrane
| Study group | Role | What they receive |
|---|---|---|
| Implant installation with PRF | Experimental | PRF membrane over the buccal aspect of implant site Receives: Procedure: Implant installation with PRF membrane |
| Implant installation without PRF | Active comparator | Implant installation contralateral to the the experimental implant, without PRF membrane Receives: Procedure: Implant installation without PRF membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).
Measured: 6 months
Secondary outcomes (2)
Keratinized tissue thickness around implant neck
Distance in mm from the surface of keratinized gingiva 1 mm apical to implant neck to bone contact
Measured: 6 months
Keratinized tissue width around implant neck
Distance in mm of keratinized tissue from implant neck to mucogingival junction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start30 Nov 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies 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
- Model description
- We will conduct a split-mouth design randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Cavalla, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429373
- Sponsor's protocol ID
- ORF42004
- Acronym
- PRF
- Status last verified
- Apr 2021
- First submitted
- 9 Jun 2020
- Last updated
- 22 Apr 2021
- 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 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth
- ClinicalTrials.gov ID
- NCT04429373
- Acronym / sponsor ID
- PRF / ORF42004
- Conditions
- Edentulous Jaw, Dental Implant Failed
- Keywords
- dental implants, platelet-rich plasm, edentulous jaw
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 12 Jun 2020 (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.
Implant retained overdentures are a cost-effective treatment for elderly patients suffering from complete tooth loss. Despite the high success rate of implants in the general population, older adults lacking all teeth are a challenging population for implant therapy, often presenting limited bone disponibility, narrow alveolar ridges, diminished bone density, scarce inserted gingiva and several co-morbidities.Thus, improving their possibility of success in implant therapy avoiding further surgical interventions is key.
Platelet-rich fibrin (PRF) is a blood derivate that can be easily and economically obtained from patients and that has shown promise of reducing the complications and improving the success of implant therapy, nevertheless its benefits in patients receiving implant retained overdentures has not been stablished. It is possible that PRF can improve the results and diminish the complications of implant therapy in older adults.
The investigation aims to demonstrate that the use of platelet-rich fibirn (PRF) is safe and beneficial for implant treatment in older adults suffering from complete tooth loss.
Detailed description
The investigators will conduct a split-mouth design randomized clinical trial assessing the effect of PRF in primary stability and bone/soft tissue healing around mandibular implants in edentulous elderly adults.
Aim and purpose
- To assess the effect of PRF on primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).
- To evaluate the effect of PRF on clinical parameters related to soft tissue healing, post-surgical pain/inflammation and early complications of mandibular implants in edentulous patients.
- To examine soft tissues volumetric changes pre and post- surgery using intraoral scans and bone changes using cone-beam computed tomography (CBCT) around mandibular implants in edentulous patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We will conduct a split-mouth design randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Implant installation with PRF | Experimental | Procedure: Implant installation with PRF membranePRF membrane over the buccal aspect of implant site |
| Implant installation without PRF | Active comparator | Procedure: Implant installation without PRF membraneImplant installation contralateral to the the experimental implant, without PRF membrane |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mandibular edentulous
- > 60 years old
Key exclusion criteria (3 listed)
- physical or psychological impediment for dental surgery
- dental extraction < 6 months in the mandible
- anticoagulant treatment
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 |
|---|---|---|
| Implant installation with PRF membranePlatelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation | Procedure or surgery | Implant installation with PRF |
| Implant installation without PRF membraneImplant installation contralateral to the experimental side without PRF membrane | Procedure or surgery | Implant installation without PRF |
Primary outcome
Implant stability
Time frame: 6 months
primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).
2 secondary outcomes
Keratinized tissue thickness around implant neck
Time frame: 6 months
Keratinized tissue width around implant neck
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Edentulous Jaw
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Recruiting
Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
Chewing Efficiency in Completely Edentulous Patients Rehabilitated With Implant-Supported Full-Arch Prostheses
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Jaw, Edentulous, Partially
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant installation with PRF membrane and Implant installation without PRF membrane in people with Edentulous Jaw and Dental Implant Failed, run by University of Chile at 1 site in Chile.
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 2 inclusion and 3 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 22 Apr 2021. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franco Cavalla, DDS PhD (+56932035746, icavalla@odontologia.uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability (time frame: 6 months). 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 22 Apr 2021.