Sticky BonePhase 4IPRFNCT05211362
Sticky Bone and Repeated Injectable PRF (iPRF) Application in Management of Periodontal Intrabony Defects
A Phase 4 study testing Sticky Bone and Repeated Injectable PRF (iPRF) and bone substitute in people with Sticky Bone and iPRF, run by Al-Azhar University at 1 site in Egypt.
Trial summary
One of the main objectives of periodontal therapy is the regeneration of the tooth's supporting periodontal tissue to its original levels. The healing after non-surgical and conventional surgical methods is histologically characterized by a long junctional epithelium along the root surfaces. Read more about this study
- Who is it for?
- Ages 18 to 48 yearsHealthy volunteers can take part
- Conditions the study is for
- Sticky Bone, iPRF, Periodontal Defect
- What is being tested?
- Sticky Bone and Repeated Injectable PRF (iPRF) and bone substitute
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2022to 22 Nov 2022
- Phase
- Phase 4
- 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 48 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No systemic diseases which could influence the outcome of therapy.
- Good compliance with plaque control instructions following initial therapy.
- Teeth involved were all vital with no mobility.
- Each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement
- Selected intrabony defects (IBD) measured from the alveolar crest to the defect base in diagnostic periapical radiographs of ≥ 3 mm, the width of ≥ 3 mm at its most coronal part, with no cratering that involve both mesial and distal surfaces of adjacent teeth.
- Selected probing depth (PD) ≥ 6 mm and clinical attachment loss (CAL) ≥ 4 mm at the site of intraosseous defects four weeks following initial cause-related therapy.
- Availability for the follow-up and maintenance program; 8) absence of periodontal treatment during the previous year.
Who cannot join
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sticky Bone and Repeated Injectable PRF Application in Management of Periodontal Intrabony Defects (Randomized Clinical Trial)
One of the main objectives of periodontal therapy is the regeneration of the tooth's supporting periodontal tissue to its original levels. The healing after non-surgical and conventional surgical methods is histologically characterized by a long junctional epithelium along the root surfaces. Therefore, reconstructive techniques are required. Although complete periodontal regeneration is unpredictable with any regenerative therapy currently used, so the objective of our trial is to get complete periodontal regeneration by using Sticky Bone and Repeated Injectable PRF (iPRF) in Management of Periodontal Intrabony Defects.
- Conditions
- Sticky Bone, iPRF, Periodontal Defect
- Being tested
- Sticky Bone and Repeated Injectable PRF (iPRF), bone substitute
- Keywords
- iPRF, sticky bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sticky Bone and Repeated Injectable PRF (iPRF)Biological
The surgical treatment phase was initiated only if the subjects had a full-mouth dental plaque score of less than one and a test site plaque score of 0. Following mucoperiosteal flap reflection for one tooth on either side of the defect, all granulation tissue was removed from the defects by means of Gracey 7/8 metal curettes, and root surfaces were scaled and planed using hand and ultrasonic instruments, then the defect was filled with xenograft mixed with IPRF, Finally, the flap was replaced and closed with crossed horizontal and vertical internal mattress sutures.
bone substituteBiological
The surgical treatment phase was initiated only if the subjects had a full-mouth dental plaque score of less than one and a test site plaque score of 0. Following mucoperiosteal flap reflection for one tooth on either side of the defect, all granulation tissue was removed from the defects by means of Gracey 7/8 metal curettes, and root surfaces were scaled and planed using hand and ultrasonic instruments, bone graft substitute was heavily condensed into the intra bony defects. The flap was replaced and closed with crossed horizontal and vertical internal mattress sutures.
| Study group | Role | What they receive |
|---|---|---|
| Sticky Bone and Repeated Injectable PRF (iPRF) | Experimental | The surgical treatment phase was initiated only if the subjects had a full-mouth dental plaque score of less than one and a test site plaque score of 0. Following mucoperiosteal flap reflection for one tooth on either side of the defect, all granulation tissue was removed from the defects by means of Gracey 7/8 metal curettes, and root surfaces were scaled and planed using hand and ultrasonic instruments, then the defect was filled with xenograft mixed with IPRF, Finally, the flap was replaced and closed with crossed horizontal and vertical internal mattress sutures. Receives: Biological: Sticky Bone and Repeated Injectable PRF (iPRF) |
| bone substitute | Active comparator | The surgical treatment phase was initiated only if the subjects had a full-mouth dental plaque score of less than one and a test site plaque score of 0. Following mucoperiosteal flap reflection for one tooth on either side of the defect, all granulation tissue was removed from the defects by means of Gracey 7/8 metal curettes, and root surfaces were scaled and planed using hand and ultrasonic instruments, bone graft substitute was heavily condensed into the intra bony defects. The flap was replaced and closed with crossed horizontal and vertical internal mattress sutures. Receives: Biological: bone substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in clinical attachment level
change in clinical attachment level
Measured: baseline, 3, and 6 months
Secondary outcomes (1)
change in interseptal bone width
change in interseptal bone width
Measured: baseline, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start16 Apr 2022 (estimated)
- Primary completion25 Aug 2022 (estimated)
- Study completion22 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sticky BoneStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmoud eldestawy, Al-Azhar University
- Investigators
- mahmoud eldestawy, associted profissor, Principal investigator, al azhar universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211362
- Sponsor's protocol ID
- 748/2757
- Acronym
- IPRF
- Status last verified
- Mar 2022
- First submitted
- 12 Jan 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sticky Bone and Repeated Injectable PRF Application in Management of Periodontal Intrabony Defects (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05211362
- Acronym / sponsor ID
- IPRF / 748/2757
- Conditions
- Sticky Bone, iPRF, Periodontal Defect
- Keywords
- iPRF, sticky bone graft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 16 Apr 2022 (estimated)
- Primary completion
- 25 Aug 2022 (estimated)
- Study completion
- 22 Nov 2022 (estimated)
- First posted
- 27 Jan 2022 (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.
One of the main objectives of periodontal therapy is the regeneration of the tooth's supporting periodontal tissue to its original levels. The healing after non-surgical and conventional surgical methods is histologically characterized by a long junctional epithelium along the root surfaces. Therefore, reconstructive techniques are required. Although complete periodontal regeneration is unpredictable with any regenerative therapy currently used, so the objective of our trial is to get complete periodontal regeneration by using Sticky Bone and Repeated Injectable PRF (iPRF) in Management of Periodontal Intrabony Defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sticky Bone and Repeated Injectable PRF (iPRF) | Experimental | Biological: Sticky Bone and Repeated Injectable PRF (iPRF)The surgical treatment phase was initiated only if the subjects had a full-mouth dental plaque score of less than one and a test site plaque score of 0. Following mucoperiosteal flap reflection for one tooth on either side of the defect, all granulation tissue was removed from the defects by means of Gracey 7/8 metal curettes, and root surfaces were scaled and planed using hand and ultrasonic instruments, then the defect was filled with xenograft mixed with IPRF, Finally, the flap was replaced and closed with crossed horizontal and vertical internal mattress sutures. |
| bone substitute | Active comparator | Biological: bone substituteThe surgical treatment phase was initiated only if the subjects had a full-mouth dental plaque score of less than one and a test site plaque score of 0. Following mucoperiosteal flap reflection for one tooth on either side of the defect, all granulation tissue was removed from the defects by means of Gracey 7/8 metal curettes, and root surfaces were scaled and planed using hand and ultrasonic instruments, bone graft substitute was heavily condensed into the intra bony defects. The flap was replaced and closed with crossed horizontal and vertical internal mattress sutures. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- No systemic diseases which could influence the outcome of therapy.
- Good compliance with plaque control instructions following initial therapy.
- Teeth involved were all vital with no mobility.
- Each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement
- Selected intrabony defects (IBD) measured from the alveolar crest to the defect base in diagnostic periapical radiographs of ≥ 3 mm, the width of ≥ 3 mm at its most coronal part, with no cratering that involve both mesial and distal surfaces of adjacent teeth.
Key exclusion criteria (1 listed)
- Pregnant females.
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 |
|---|---|---|
| Sticky Bone and Repeated Injectable PRF (iPRF)The surgical treatment phase was initiated only if the subjects had a full-mouth dental plaque score of less than one and a test site plaque score of 0. Following mucoperiosteal flap reflection for one tooth on either side of the defect, all granulation tissue was removed from the defects by means of Gracey 7/8 metal curettes, and root surfaces were scaled and planed using hand and ultrasonic instruments, then the defect was filled with xenograft mixed with IPRF, Finally, the flap was replaced and closed with crossed horizontal and vertical internal mattress sutures. | Biological | Sticky Bone and Repeated Injectable PRF (iPRF) |
| bone substituteThe surgical treatment phase was initiated only if the subjects had a full-mouth dental plaque score of less than one and a test site plaque score of 0. Following mucoperiosteal flap reflection for one tooth on either side of the defect, all granulation tissue was removed from the defects by means of Gracey 7/8 metal curettes, and root surfaces were scaled and planed using hand and ultrasonic instruments, bone graft substitute was heavily condensed into the intra bony defects. The flap was replaced and closed with crossed horizontal and vertical internal mattress sutures. | Biological | bone substitute |
Primary outcome
change in clinical attachment level
Time frame: baseline, 3, and 6 months
change in clinical attachment level
1 secondary outcome
change in interseptal bone width
Time frame: baseline, 3, and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: Yes
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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.
mahmoud eldestawy, associted profissor principal investigator
al azhar universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sticky Bone and Repeated Injectable PRF (iPRF) and bone substitute in people with Sticky Bone and iPRF, run by Al-Azhar University at 1 site in Egypt.
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 7 inclusion and 1 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 8 Mar 2022. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Al Azhar University University (0020222628346, Azhar@azhar.eun.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in clinical attachment level (time frame: baseline, 3, and 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 8 Mar 2022.