Periodontal Bone LossNCT04043754
Platelet-rich Fibrin and Autogenous Bone vs Membrane and Autogenous Bone in Intrabony Defects
A study testing Procedure/Surgery: Periodontal surgery with Membrane and Periodontal surgery with Platlet Rich fibrin in people with Periodontal Bone Loss, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
Currently, the most positive documented outcomes of periodontal regenerative therapy (PRT) in intrabony defects (IBDs) have been achieved with a combination of bone grafts ( BGs) and a regeneration material like membranes in guided tissue regeneration ( GTR) technique. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Bone Loss
- What is being tested?
- Procedure/Surgery: Periodontal surgery with Membrane and Periodontal surgery with Platlet Rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2018to 15 Jul 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a full-mouth plaque score (FMPS) 25 and a full-mouth bleeding score (FMBS) 26 < 20% at the time of surgery
- to have at least 20 teeth,; at least 1 tooth exhibiting vertical bone loss detected by radiographic examination (alveolar crest level (ACL) - bottom of the defect (BD) distance - -Bone defect depth (BDD) ≥ 4 mm and a probing pocket depth (PPD) ≥ 5mm when evaluated 12 weeks after phase I non- surgical therapy [ scaling and root planing ( SRP)]
Who cannot join
- no systemic diseases
- no medications affecting periodontal status during the previous 6 months
- not pregnant or lactating; non-smoker
- no periodontal therapy in the 2 previous years, no inadequate endodontic treatment, no dental mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periodontal Regeneration With Platelet-rich Fibrin (Prf) and Autogenous Bone Graft (Abg) Versus Membrane and Abg in the Treatment of Intrabony Periodontal Defects a Longitudinal Randomized Control Clinical Study
Currently, the most positive documented outcomes of periodontal regenerative therapy (PRT) in intrabony defects (IBDs) have been achieved with a combination of bone grafts ( BGs) and a regeneration material like membranes in guided tissue regeneration ( GTR) technique. Among the graft materials only autogenous bone grafts ( ABGs).and demineralized freeze-dried bone allografts (DFDBA), are considered regenerative materials.
Polypeptide growth factors revealed a potential application in PRT periodontal because are the biological mediators during wound healing and regeneration and autologous platelet concentrates ( PC) constitute a safe and convenient approach to deliver them.
Read more
Among PC, platelet-rich fibrin ( PRF) belongs to a group of second-generation blood autologous products prepared by peripheral blood centrifugation without any nonclotting agent, so to obtain a dense three-dimensional clot architecture that concentrates platelets, fibrin, leukocytes, cytokines, and sustain cellular migration. This clot is then compressed to obtain elastic and very strong membranes that can be used directly as membranes or as an agent, after chopping, alone or in combination with BGs.
Several studies demonstrate that PRF is effective in promoting bone regeneration (BR) when used alone or in combination with BG during oral/ periodontal surgery.
To date, there are very few published clinical controlled trials that compare the results of PRF + BGs to the outcomes of PRF / BG alone in the treatment of IBDs and no study about PRF + ABG in the same defects. Only one case report tested the use of PRF + ABG mixed with bovine hydroxyapatite in the treatment of insufficient alveolar ridge width in aesthetic area. The aim of the present study is to verify if the combined use of PRF + ABG in the management of IBDs may be a treatment modality clinically "not inferior" to that with Membrane + ABG.
Read the detailed description
This is a prospective, randomized and controlled clinical trial designed to evaluate the clinical and radiographic outcomes 12 months after two treatment modalities of IBDs: PRF + ABG into defects in the test subjects( TS); membrane + ABG in the control subjects ( CS). The patients enrolled exhibit unfavourable IBDs and all experimental sites will be accessed with a simplified papilla preservation flap ( SPPF) procedure. The filling material (ABG) is common to both treatments: therefore, the investigation will focus on the addictive effect of PRF used in place of MEMBRANE. MEMBRANE is chosen as the active control ( AC) as it is currently considered as the biological "gold standard" agent for the treatment of IBDs.
A non-inferiority trial ( NIT) is designed to prove that using PRF instead of MEMBRANE could achieve a similar result, reducing the treatment's cost and allowing the clinicians to use autogenous material only.
An AC (comparator) is present, but the investigators do not include a third experimental arm, a group of IBDs treated using Open Flap Debridement ( OFD) alone, as it is widely accepted in NITs.
The estimate of the AC effect vs. placebo is assumed from a recent meta-analysis, by the Lower Bound of a 95% Confidence Interval ( CI) of the mean of MEMBRANE + ABG, while an OFD estimate from the corresponding 95%.. The difference between estimates is set as the added benefit of the AC and as a ground for the assay sensitivity.
44 patients affected by moderate-to-severe chronic periodontitis, will be selected for the study. Each patient will participate in the study with a single experimental site. The participants will receive verbal and written information and they will sign a consent form approved by the Ethical Committee of the G. DAnnunzio University of Chieti - medical faculty. The study protocol is in accordance with the Declaration of Helsinki of 1975, revised in Tokyo in 2004. Four months before the surgical treatment, all 44 patients will undergo SRP by ultrasonic instruments and hand curettes and motivational instructions on oral home care.
Non-inferiority margin. A reliable estimate of the expected clinical attachment level ( CAL) gain from an MEMBRANE+ ABG treatment is drawn from a recent meta-analysis, reporting on 548 IBDs in 434 patients.
By literature, CAL gain obtainable by OFD surgical treatments alone is 2.47 mm. The differential effect of using MEMBRANE amounts about 1 .
Each defect will be assigned a defect number and will be randomly allocated to one of the two treatment regimens. Assignment will be performed by a custom made computer-generated table. To conceal allocation, opaque envelopes will be assigned to the specific experimental site and will be opened during surgery Preoperative and 3- 6- 12-months postoperative intraoral standardized radiographs will be taken by the paralleling technique using an individual film-holder device consisting of a bite block rigidly connected to an acrylic dental splint to achieve identical film placement at each evaluation. Pre- and postoperative radiographs will be evaluated by two experienced clinicians who will be masked with respect to the provenience of the radiographs and the clinical measurements. The positions of alveolar crest level and of the bottom of the defect distance and will be marked by a pencil on the radiographs and bottom of the defect will be measured by a millimeter grid. Linear distances between the most coronal interproximal alveolar crest level and the bottom of the defect will be obtained by counting the walls
- Conditions
- Periodontal Bone Loss
- Being tested
- Procedure/Surgery: Periodontal surgery with Membrane, Periodontal surgery with Platlet Rich fibrin
- 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.
Procedure/Surgery: Periodontal surgery with MembraneProcedure or surgery
Patients will be treated by periodontal surgical flaps with the addition of Membrane+ bone graft
Periodontal surgery with Platlet Rich fibrinProcedure or surgery
Patients will be treated by periodontal surgical flaps with the addition of PRF + bone graft
| Study group | Role | What they receive |
|---|---|---|
| PRF treated patients | Experimental | Periodontal surgery with Platelet Rich Fibrin is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. Autogenous corticocancellous BG material will be collected using bone scrapers , the PRF membrane cut into small pieces and mixed with the ABG will be placed within the IBDs until they will be completely filled. Then the other two PRF membranes in each patient will be adapted over the grafted defect Finally horizontal mattress and interrupted sutures will be carried out. Receives: Procedure: Periodontal surgery with Platlet Rich fibrin |
| GTR treated patients | Active comparator | Periodontal surgery with MEMBRANE is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. Autogenous corticocancellous BG material will be collected using bone scrapers ; then, ABG will be applied alternatively with MEMBRANE into the IBD according to the "sandwich" technique until the IBD will be completely filled. Finally the flap will be repositioned and sutures completed by interrupted sutures. Receives: Procedure: Procedure/Surgery: Periodontal surgery with Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal attachment gain
Change of the distance between the cementum-enamel junction and the depth of the probable site
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 posted2 Aug 2019
- Study start10 Jun 2018
- Primary completion16 Mar 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Paolantonio, G. d'Annunzio University
- Investigators
- michele paolantonio, Principal investigator, università G. D'annunzio Chieti-Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043754
- Sponsor's protocol ID
- 062019
- Status last verified
- Jun 2024
- First submitted
- 30 Jul 2019
- Last updated
- 1 Jul 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Regeneration With Platelet-rich Fibrin (Prf) and Autogenous Bone Graft (Abg) Versus Membrane and Abg in the Treatment of Intrabony Periodontal Defects a Longitudinal Randomized Control Clinical Study
- ClinicalTrials.gov ID
- NCT04043754
- Acronym / sponsor ID
- 062019
- Conditions
- Periodontal Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 2 Aug 2019 (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.
Currently, the most positive documented outcomes of periodontal regenerative therapy (PRT) in intrabony defects (IBDs) have been achieved with a combination of bone grafts ( BGs) and a regeneration material like membranes in guided tissue regeneration ( GTR) technique. Among the graft materials only autogenous bone grafts ( ABGs).and demineralized freeze-dried bone allografts (DFDBA), are considered regenerative materials.
Polypeptide growth factors revealed a potential application in PRT periodontal because are the biological mediators during wound healing and regeneration and autologous platelet concentrates ( PC) constitute a safe and convenient approach to deliver them.
Among PC, platelet-rich fibrin ( PRF) belongs to a group of second-generation blood autologous products prepared by peripheral blood centrifugation without any nonclotting agent, so to obtain a dense three-dimensional clot architecture that concentrates platelets, fibrin, leukocytes, cytokines, and sustain cellular migration. This clot is then compressed to obtain elastic and very strong membranes that can be used directly as membranes or as an agent, after chopping, alone or in combination with BGs.
Several studies demonstrate that PRF is effective in promoting bone regeneration (BR) when used alone or in combination with BG during oral/ periodontal surgery.
To date, there are very few published clinical controlled trials that compare the results of PRF + BGs to the outcomes of PRF / BG alone in the treatment of IBDs and no study about PRF + ABG in the same defects. Only one case report tested the use of PRF + ABG mixed with bovine hydroxyapatite in the treatment of insufficient alveolar ridge width in aesthetic area. The aim of the present study is to verify if the combined use of PRF + ABG in the management of IBDs may be a treatment modality clinically "not inferior" to that with Membrane + ABG.
Detailed description
This is a prospective, randomized and controlled clinical trial designed to evaluate the clinical and radiographic outcomes 12 months after two treatment modalities of IBDs: PRF + ABG into defects in the test subjects( TS); membrane + ABG in the control subjects ( CS). The patients enrolled exhibit unfavourable IBDs and all experimental sites will be accessed with a simplified papilla preservation flap ( SPPF) procedure. The filling material (ABG) is common to both treatments: therefore, the investigation will focus on the addictive effect of PRF used in place of MEMBRANE. MEMBRANE is chosen as the active control ( AC) as it is currently considered as the biological "gold standard" agent for the treatment of IBDs.
A non-inferiority trial ( NIT) is designed to prove that using PRF instead of MEMBRANE could achieve a similar result, reducing the treatment's cost and allowing the clinicians to use autogenous material only.
An AC (comparator) is present, but the investigators do not include a third experimental arm, a group of IBDs treated using Open Flap Debridement ( OFD) alone, as it is widely accepted in NITs.
The estimate of the AC effect vs. placebo is assumed from a recent meta-analysis, by the Lower Bound of a 95% Confidence Interval ( CI) of the mean of MEMBRANE + ABG, while an OFD estimate from the corresponding 95%.. The difference between estimates is set as the added benefit of the AC and as a ground for the assay sensitivity.
44 patients affected by moderate-to-severe chronic periodontitis, will be selected for the study. Each patient will participate in the study with a single experimental site. The participants will receive verbal and written information and they will sign a consent form approved by the Ethical Committee of the G. DAnnunzio University of Chieti - medical faculty. The study protocol is in accordance with the Declaration of Helsinki of 1975, revised in Tokyo in 2004. Four months before the surgical treatment, all 44 patients will undergo SRP by ultrasonic instruments and hand curettes and motivational instructions on oral home care.
Non-inferiority margin. A reliable estimate of the expected clinical attachment level ( CAL) gain from an MEMBRANE+ ABG treatment is drawn from a recent meta-analysis, reporting on 548 IBDs in 434 patients.
By literature, CAL gain obtainable by OFD surgical treatments alone is 2.47 mm. The differential effect of using MEMBRANE amounts about 1 .
Each defect will be assigned a defect number and will be randomly allocated to one of the two treatment regimens. Assignment will be performed by a custom made computer-generated table. To conceal allocation, opaque envelopes will be assigned to the specific experimental site and will be opened during surgery Preoperative and 3- 6- 12-months postoperative intraoral standardized radiographs will be taken by the paralleling technique using an individual film-holder device consisting of a bite block rigidly connected to an acrylic dental splint to achieve identical film placement at each evaluation. Pre- and postoperative radiographs will be evaluated by two experienced clinicians who will be masked with respect to the provenience of the radiographs and the clinical measurements. The positions of alveolar crest level and of the bottom of the defect distance and will be marked by a pencil on the radiographs and bottom of the defect will be measured by a millimeter grid. Linear distances between the most coronal interproximal alveolar crest level and the bottom of the defect will be obtained by counting the walls
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF treated patients | Experimental | Procedure: Periodontal surgery with Platlet Rich fibrinPeriodontal surgery with Platelet Rich Fibrin is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. Autogenous corticocancellous BG material will be collected using bone scrapers , the PRF membrane cut into small pieces and mixed with the ABG will be placed within the IBDs until they will be completely filled. Then the other two PRF membranes in each patient will be adapted over the grafted defect Finally horizontal mattress and interrupted sutures will be carried out. |
| GTR treated patients | Active comparator | Procedure: Procedure/Surgery: Periodontal surgery with MembranePeriodontal surgery with MEMBRANE is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. Autogenous corticocancellous BG material will be collected using bone scrapers ; then, ABG will be applied alternatively with MEMBRANE into the IBD according to the "sandwich" technique until the IBD will be completely filled. Finally the flap will be repositioned and sutures completed by interrupted sutures. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a full-mouth plaque score (FMPS) 25 and a full-mouth bleeding score (FMBS) 26 < 20% at the time of surgery
- to have at least 20 teeth,; at least 1 tooth exhibiting vertical bone loss detected by radiographic examination (alveolar crest level (ACL) - bottom of the defect (BD) distance - -Bone defect depth (BDD) ≥ 4 mm and a probing pocket depth (PPD) ≥ 5mm when evaluated 12 weeks after phase I non- surgical therapy [ scaling and root planing ( SRP)]
Key exclusion criteria (4 listed)
- no systemic diseases
- no medications affecting periodontal status during the previous 6 months
- not pregnant or lactating; non-smoker
- no periodontal therapy in the 2 previous years, no inadequate endodontic treatment, no dental mobility
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 |
|---|---|---|
| Procedure/Surgery: Periodontal surgery with MembranePatients will be treated by periodontal surgical flaps with the addition of Membrane+ bone graft | Procedure or surgery | GTR treated patients |
| Periodontal surgery with Platlet Rich fibrinPatients will be treated by periodontal surgical flaps with the addition of PRF + bone graft | Procedure or surgery | PRF treated patients |
Primary outcome
Periodontal attachment gain
Time frame: 6 months
Change of the distance between the cementum-enamel junction and the depth of the probable site
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 1 Jul 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.
michele paolantonio principal investigator
università G. D'annunzio Chieti-Pescara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure/Surgery: Periodontal surgery with Membrane and Periodontal surgery with Platlet Rich fibrin in people with Periodontal Bone Loss, run by G. d'Annunzio University at 1 site in Italy.
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 4 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 1 Jul 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 Italy. 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?
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?
Periodontal attachment gain (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 1 Jul 2024.