PeriodontitisNCT03804086
Evaluation of Advanced PRF Combined With Nano-crystalline Hydroxyapatite for Management of Grade II Furcation Defects
A study testing Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement and Open flap debridement in people with Periodontitis, run by Hadeer Ashraf Hassan Roushdy.
Trial summary
this study is to evaluate the use of advanced platelet rich fibrin (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) versus open flap debridement alone in the management of mandibular molar grade II defects. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement and Open flap debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Feb 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient-related criteria:
- Systemically healthy patients.
- Compliance with oral hygiene instructions and the maintenance program provided.
- Accepts the 6 months follow-up period.
- Provide informed consent.
- Teeth related criteria:
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- Mature permanent tooth.
- Asymptomatic mandibular molar with buccal Glickman class II furcation involvement.
- Probing depth (PD) ≥ 5 mm and vertical PD ≥ 3 mm after Phase I therapy (scaling and root planing).
- Presence of radiolucency in the furcation area on an intra-oral periapical radiograph
Who cannot join
- Patient-related criteria:
- Patients taking drugs known to interfere with periodontal wound healing in the last six months.
- Pregnant or nursing women.
- Smokers.
- Uncooperative patients.
- Teeth related criteria:
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- Teeth with interproximal supra-bony or intrabony defects.
- Teeth with gingival recession.
- Teeth with grade II or III mobility.
About this study
Official title: Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin Combined With Nano-crystalline Hydroxyapatite Bone Substitute for Management of Mandibular Molar Grade II Furcation Defects
this study is to evaluate the use of advanced platelet rich fibrin (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) versus open flap debridement alone in the management of mandibular molar grade II defects.
In the management of mandibular molar grade II furcation defects, no difference exists in gain of horizontal clinical attachment level between the use of advanced platelet rich fibrin (A-PRF) + with nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) and open flap debridement (OPD) alone .
- Conditions
- Periodontitis
- Being tested
- Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement, Open flap debridement
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridementProcedure or surgery
will treated with OFD +A- PRF+ nano-crystalline hydroxyapatite bone substitute,10 mL of blood will be drawn from only patient assigned to the intervention group by vein puncture of the antecubital vein and is collected in sterile glass test tube, without any anticoagulant.
- The blood will be quickly collected, and the tube will immediately centrifuge at 1500 rpm for14 min at room temperature.
- After centrifugation, the A-PRF clot will be removed from the tube using sterile tweezers and placed on sterile woven gauze. Membrane will prepared by compressing clots between two pieces of woven gauze.
Open flap debridementProcedure or surgery
a periodontal access flap will be initiated by intrasulcular incisions on the buccal and lingual aspects. The incisions will be carried as far interproximally as possible to preserve the entire Interdental papillae and to achieve primary wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OFD). Receives: Procedure: Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement |
| Control Group | Active comparator | Open flap debridement alone. Receives: Procedure: Open flap debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Vertical Clinical Attachment Level (RVCAL)
relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe
Measured: 6 months
Secondary outcomes (3)
Relative Horizontal Clinical Attachment Level (PHCAL)
relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe
Measured: 6 months
Probing Depth (PD)
Probing depth measured from the gingival margin to the base of the pocket.
Measured: 6 months
Gingival margin Level (GML)
- Williams graduated probe will be used for vertical measurement and gingival margin level and Nabers probe for horizontal measurements.
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 posted15 Jan 2019
- Study startFeb 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadeer Ashraf Hassan Roushdy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hadeer Ashraf Hassan Roushdy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804086
- Sponsor's protocol ID
- perio2019
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2019
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin Combined With Nano-crystalline Hydroxyapatite Bone Substitute for Management of Mandibular Molar Grade II Furcation Defects
- ClinicalTrials.gov ID
- NCT03804086
- Acronym / sponsor ID
- perio2019
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hadeer Ashraf Hassan RoushdyUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 15 Jan 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.
this study is to evaluate the use of advanced platelet rich fibrin (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) versus open flap debridement alone in the management of mandibular molar grade II defects.
In the management of mandibular molar grade II furcation defects, no difference exists in gain of horizontal clinical attachment level between the use of advanced platelet rich fibrin (A-PRF) + with nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) and open flap debridement (OPD) alone .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Procedure: Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridementAdvanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OFD). |
| Control Group | Active comparator | Procedure: Open flap debridementOpen flap debridement alone. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Systemically healthy patients.
- Compliance with oral hygiene instructions and the maintenance program provided.
- Accepts the 6 months follow-up period.
- Provide informed consent.
- Mature permanent tooth.
Key exclusion criteria (9 listed)
- Patients taking drugs known to interfere with periodontal wound healing in the last six months.
- Pregnant or nursing women.
- Smokers.
- Uncooperative patients.
- Teeth with interproximal supra-bony or intrabony defects.
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 |
|---|---|---|
| Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridementwill treated with OFD +A- PRF+ nano-crystalline hydroxyapatite bone substitute,10 mL of blood will be drawn from only patient assigned to the intervention group by vein puncture of the antecubital vein and is collected in sterile glass test tube, without any anticoagulant. * The blood will be quickly collected, and the tube will immediately centrifuge at 1500 rpm for14 min at room temperature. * After centrifugation, the A-PRF clot will be removed from the tube using sterile tweezers and placed on sterile woven gauze. Membrane will prepared by compressing clots between two pieces of woven gauze. | Procedure or surgery | Test Group |
| Open flap debridementa periodontal access flap will be initiated by intrasulcular incisions on the buccal and lingual aspects. The incisions will be carried as far interproximally as possible to preserve the entire Interdental papillae and to achieve primary wound closure. | Procedure or surgery | Control Group |
Primary outcome
Relative Vertical Clinical Attachment Level (RVCAL)
Time frame: 6 months
relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe
3 secondary outcomes
Relative Horizontal Clinical Attachment Level (PHCAL)
Time frame: 6 months
Probing Depth (PD)
Time frame: 6 months
Gingival margin Level (GML)
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 17 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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 Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement and Open flap debridement in people with Periodontitis, run by Hadeer Ashraf Hassan Roushdy.
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 10 inclusion and 9 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 17 Jan 2019. 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?
Relative Vertical Clinical Attachment Level (RVCAL) (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 17 Jan 2019.