Bony DefectsEarly Phase 1NCT02810548
Evaluation of Platelets Rich Fibrin and Nanohydroxyapatite in the Treatment of Intrabony Defects
A Early Phase 1 study testing OFD alone, Platelet rich Fibrin and Nanohydroxyapatite in people with Bony Defects, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. Researches had demonstrated the benefits of platelet concentrates bine grafts in osseous regeneration in the areas of periodontal surgery. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bony Defects
- What is being tested?
- OFD alone, Platelet rich Fibrin and Nanohydroxyapatite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2015to 30 Nov 2016
- Phase
- Early Phase 1
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients are free from systemic illness.
- All patients should be diagnosed as having chronic periodontitis.
- Patients should be cooperative, motivated and willing to follow our treatment protocol and follow up visits.
- Patients selected had not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination.
Who cannot join
- Presence of areas of periodontal pocket of (probing depth ≥5 and clinical attachment level (CAL) ≥ 3).
- Patients who have received any type of periodontal treatment in the past 6 months prior to examination.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdelaziz University. Faculty of dentistry
Jeddah, 21589
About this study
Official title: Clinical and Biochemical Evaluation of Platelets Rich Fibrin (PRF) and Nanohydroxyapatite in the Treatment of Intrabony Defects
Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. Researches had demonstrated the benefits of platelet concentrates bine grafts in osseous regeneration in the areas of periodontal surgery.
Aim of the study: to evaluate the effect of PRF with/without nanohydroxyapatite in periodontal intrabony defects.
Read the detailed description
Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. The regenerative and wound healing potential of platelets has attracted much attention over the last few years. Researches had demonstrated the benefits of platelet concentrates in osseous regeneration in the areas of periodontal surgery and implantology. In addition, nanohydroxyapatite was shown to be unsheathed by newly formed bone and partly replaced by it, but resorbed very slowly, as shown in animal experiments after 9 months or in clinical studies after a 6-month observation period. The clinical and biochemical studies evaluating the regenerative effect of PRF alone or in combination with nanohydroxyapatite in periodontal intrabony defects are still deficient.
Aim of the study: to evaluate clinical and biochemical effect of PRF with/without nanohydroxyapatite in treatment of human intrabony defects.
- Conditions
- Bony Defects
- Being tested
- OFD alone, Platelet rich Fibrin, Nanohydroxyapatite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFD aloneProcedure or surgery
Also called Periodontal Surgery
Periodontal surgical cleaning procedure
Platelet rich FibrinDrug
Also called Natural growth factor
Natural platelet concentrate rich in growth factors
NanohydroxyapatiteDrug
Also called Bone graft
Synthetic bone graft
| Study group | Role | What they receive |
|---|---|---|
| OFD alone | Placebo comparator | Control group: including 15 defects that will receive open flap debridement (OFD). Receives: Procedure: OFD alone |
| PRF + OFD | Active comparator | Test group (1): including 15 defects that will receive platelet rich fibrin (PRF) with open flap debridement (OFD). Receives: Procedure: OFD alone; Drug: Platelet rich Fibrin |
| Bone + OFD | Active comparator | Test group (2): including 15 defects that will receive nanohydroxyapatite bone graft with open flap debridement OFD). Receives: Procedure: OFD alone; Drug: Nanohydroxyapatite |
| PRF + Bone + OFD | Active comparator | Test group (3): including 15 defects that will receive nanohydroxyapatite bone graft with platelet rich fibrin (PRF) after open flap debridement (OFD). Receives: Procedure: OFD alone; Drug: Platelet rich Fibrin; Drug: Nanohydroxyapatite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gingival crevicular fluid (GCF)
GCF will be collected after removing saliva and supra-gingival plaque using methylcellulose filter paper strip that will be inserted in the periodontal pocket and will be let in for 30 seconds.
Measured: up to 3 weeks.
Secondary outcomes (3)
Changes in Gingival index
Gingival index (GI) developed on 1963.
Measured: up to 3 months
Changes in level of attachment loss
Attachment loss: will be measured from the cemento-enamel junction (CEJ) to the apical part of the sulcus.
Measured: up to 3 months
Changes in probing pocket depth
Probing pocket depth (PD): six measurements per tooth will be recorded by using the University of Michigan O periodontal probe with Williams markings.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start1 Feb 2015
- Primary completion15 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bony DefectsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha A. Bahammam, King Abdulaziz University
- Investigators
- Maha A Bahammam, DSc, Principal investigator, King Abdelaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810548
- Sponsor's protocol ID
- 032-16
- Status last verified
- Mar 2024
- First submitted
- 8 Jun 2016
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Evaluation of Platelets Rich Fibrin (PRF) and Nanohydroxyapatite in the Treatment of Intrabony Defects
- ClinicalTrials.gov ID
- NCT02810548
- Acronym / sponsor ID
- 032-16
- Conditions
- Bony Defects
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 23 Jun 2016 (estimated)
- 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.
Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. Researches had demonstrated the benefits of platelet concentrates bine grafts in osseous regeneration in the areas of periodontal surgery.
Aim of the study: to evaluate the effect of PRF with/without nanohydroxyapatite in periodontal intrabony defects.
Detailed description
Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. The regenerative and wound healing potential of platelets has attracted much attention over the last few years. Researches had demonstrated the benefits of platelet concentrates in osseous regeneration in the areas of periodontal surgery and implantology. In addition, nanohydroxyapatite was shown to be unsheathed by newly formed bone and partly replaced by it, but resorbed very slowly, as shown in animal experiments after 9 months or in clinical studies after a 6-month observation period. The clinical and biochemical studies evaluating the regenerative effect of PRF alone or in combination with nanohydroxyapatite in periodontal intrabony defects are still deficient.
Aim of the study: to evaluate clinical and biochemical effect of PRF with/without nanohydroxyapatite in treatment of human intrabony defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OFD alone | Placebo comparator | Procedure: OFD aloneControl group: including 15 defects that will receive open flap debridement (OFD). |
| PRF + OFD | Active comparator | Procedure: OFD alone, Drug: Platelet rich FibrinTest group (1): including 15 defects that will receive platelet rich fibrin (PRF) with open flap debridement (OFD). |
| Bone + OFD | Active comparator | Procedure: OFD alone, Drug: NanohydroxyapatiteTest group (2): including 15 defects that will receive nanohydroxyapatite bone graft with open flap debridement OFD). |
| PRF + Bone + OFD | Active comparator | Procedure: OFD alone, Drug: Platelet rich Fibrin, Drug: NanohydroxyapatiteTest group (3): including 15 defects that will receive nanohydroxyapatite bone graft with platelet rich fibrin (PRF) after open flap debridement (OFD). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients are free from systemic illness.
- All patients should be diagnosed as having chronic periodontitis.
- Patients should be cooperative, motivated and willing to follow our treatment protocol and follow up visits.
- Patients selected had not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination.
Key exclusion criteria (2 listed)
- Presence of areas of periodontal pocket of (probing depth ≥5 and clinical attachment level (CAL) ≥ 3).
- Patients who have received any type of periodontal treatment in the past 6 months prior to examination.
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 |
|---|---|---|
| OFD aloneAlso: Periodontal SurgeryPeriodontal surgical cleaning procedure | Procedure or surgery | Bone + OFD, OFD alone, PRF + Bone + OFD, PRF + OFD |
| Platelet rich FibrinAlso: Natural growth factorNatural platelet concentrate rich in growth factors | Drug | PRF + Bone + OFD, PRF + OFD |
| NanohydroxyapatiteAlso: Bone graftSynthetic bone graft | Drug | Bone + OFD, PRF + Bone + OFD |
Primary outcome
Changes in Gingival crevicular fluid (GCF)
Time frame: up to 3 weeks.
GCF will be collected after removing saliva and supra-gingival plaque using methylcellulose filter paper strip that will be inserted in the periodontal pocket and will be let in for 30 seconds.
3 secondary outcomes
Changes in Gingival index
Time frame: up to 3 months
Changes in level of attachment loss
Time frame: up to 3 months
Changes in probing pocket depth
Time frame: up to 3 months
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 15 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.
Maha A Bahammam, DSc principal investigator
King Abdelaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing OFD alone, Platelet rich Fibrin and Nanohydroxyapatite in people with Bony Defects, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 4 inclusion and 2 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 15 Mar 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in Gingival crevicular fluid (GCF) (time frame: up to 3 weeks.). 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 15 Mar 2024.