Periodontal DiseasesNCT06641739
Photobiomodulation and Platelets Rich in Growth Factors (PRGFs)-Assisted Flap Surgery in Treating Stage III Periodontal Defects
A study testing laser assisted SPPF and Platelet Rich Plasma in people with Periodontal Diseases, run by Assiut University.
Trial summary
Stage 3 periodontitis is a condition marked by swift and severe destruction of periodontal tissues. To effectively regenerate osseous defects resulting from periodontal disease, it is crucial to leverage the intrinsic regenerative potential of the periodontium via meticulously formulated therapeutic strategies Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- laser assisted SPPF and Platelet Rich Plasma
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to 5 Feb 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with PPD =5 mm and clinical attachment loss of ≥3 mm;
- Presence of 2 walled or 3 walled infra-bony defects posterior segments;
- Evidence of ≥3 mm of intra-bony defect depth evaluated by the visualization of peri-apical radiographs.
Who cannot join
- Patients requiring antibiotic prophylaxis before the periodontal examination;
- Patients diagnosed with malocclusion at the site of the defect;
- Patients with systemic disease and/or on drugs that contraindicate periodontal surgery;
- Patients with a history of smoking and pan chewing;
- Sites with advanced class II \& III furcation involvement.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Clinical Trials of Laser Photobiomodulation and Platelets Rich in Growth Factors (PRGFs)-Assisted Flap Surgery in Treating Stage III Periodontal Defects: an In-Depth Analysis of Clinical Outcomes and Healing Processes
Stage 3 periodontitis is a condition marked by swift and severe destruction of periodontal tissues. To effectively regenerate osseous defects resulting from periodontal disease, it is crucial to leverage the intrinsic regenerative potential of the periodontium via meticulously formulated therapeutic strategies
Read the detailed description
The main treatment methods of periodontal diseases involve scaling and root planning (SRP), and periodontal surgery. Periodontopathogens, can penetrate deep by crossing the epithelial barrier which may be difficult to be remove by nonsurgical periodontal therapy (NSPT) alone. A multitude of grafted and non-grafted approaches have been used in the management of Intra-bony defects. However, they do not provide predictable periodontal regeneration.
A systematic review on the use of platelet-rich fibrin (PRF) for managing periodontal defects highlights its promising potential in periodontal regeneration. It forms a fibrin matrix that promotes angiogenesis and enhances healing at defected sites. The review emphasizes PRF's ability to sustain the release of growth factors, which are crucial for osteoblastic proliferation, migration, and adherence. This makes PRF an effective scaffold for cellular elements, facilitating periodontal tissue regeneration.
Laser photobiomodulation (PBM) has emerged as a promising adjunctive treatment as it stimulates cellular processes, enhancing the natural regenerative capabilities of periodontal tissues. Recent studies have demonstrated that PBM, particularly with diode, significantly improves clinical outcomes when combined with conventional periodontal treatments. It promotes osteoblastic proliferation, migration, and adherence, thereby facilitating bone regeneration and reducing periodontal pocket depth. Additionally, PBM enhances angiogenesis and modulates the release of growth factors, creating an optimal healing environment.
- Conditions
- Periodontal Diseases
- Being tested
- laser assisted SPPF, Platelet Rich Plasma
- Keywords
- photobiomodulation, laser therapy, PRF, stage III periodontal diseases
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser assisted SPPFDevice
A full-thickness flaps were elevated. In the test sites after the SPPF access will be performed, root surface debridement will be meticulously performed, followed by intra-marrow penetrations (IMPs), on the defect walls using a 0.25 mm wide half round bur, mounted on a slow-speed handpiece. Following this, low-level laser biostimulation of the defect will be effected with an 940 nm diode laser at 3 W power, with an uninitiated 0.6mm optical fiber tip. The defects will be irradiated for 20 seconds in a continuous noncontact mode and then retracted for 8 seconds. This will be repeated for 3 times so that the defects were effectively lased for about 60 seconds.
Platelet Rich PlasmaProcedure or surgery
In the second group, following the SPPF, the defect will grafted with particulated PRF, which will be overlaid with a PRF membrane, without any adjunctive defect management measures. PRF will be prepared by collecting Intra-venous blood (from the antecubital vein) in a 10-ml sterile glass tube without anticoagulant and immediately centrifuged in a centrifugation machine at 3000 rpm for 10 minutes. It will result in the separation of blood into a structured fibrin matrix in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma (platelet poor plasma) at the top. PPP will be discarded. PRF will be easily separated from the red corpuscles base using sterile tweezers and scissors.
| Study group | Role | What they receive |
|---|---|---|
| • Laser-treated group | Active comparator | Ten patients will be treated the simplified papilla preservation flap with laser therapy performed into the defect site. The laser used in the study is diode lasers ( 940nm), with an output power of 3 W in the contact mode. Receives: Device: laser assisted SPPF |
| platelets Rich Fibrin Graft | Active comparator | Ten patients will be treated with simplified papilla preservation flap with platelet-rich fibrin grafted into the defect site. Receives: Procedure: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
-Evaluation of the changes in the clinical attachment loss
Attachment level will be measured using UNC15(University of North Carolina) periodontal probe. Clinical attachment loss will be measured as the distance from the cemento-enamel junction to the base of the pocket.[Time Frame: at base line, 1 month and 3 months after treatment]
Measured: [Time Frame: at base line, 1 month and 3 months after treatment]
probing depth
The measurement will be recorded by UNC15(University of North Carolina) periodontal probe . Pocket depth will be measured as the distances from the free gingival margin to the base of the periodontal pocket.
Measured: [Time Frame: at base line, 1 month and 3 months after treatment]
Secondary outcomes (2)
-Plaque index (PI)
It used to assess plaque accumulation around gingival margin.
The degree of plaque accumulation was recorded as follow:
- 0= No plaque around the gingival margin.
- 1= A thin film of plaque around the gingival margin. The plaque may be recognized only by running a probe across the tooth surface.
- 2= Moderate accumulation of soft deposits on the gingival margin and/or adjacent tooth surface, which can be seen by naked eye. 3= Abundance plaque accumulation within the gingival pocket and/or on the gingival margin and adjacent tooth surface and hard deposits on the tooth surface are seen.
Measured: [Time Frame: at base line, 1 month and 3 months after treatment]
Gingival index (GI)
It used to assess gingival inflammation. The degree of gingival inflammation will be recorded as follow:
- 0 = Normal gingiva.
- 1 = Mild inflammation, slight change in color, slight edema and no bleeding on probing.
- 2= Moderate inflammation, redness, edema and bleeding on probing.
- 3= Severe inflammation, marked redness, edema and tendency to spontaneous bleeding.
Measured: [Time Frame: at base line, 1 month and 3 months after treatment]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion5 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Group 1: Ten patients will be treated with simplified papilla preservation flap with platelet-rich fibrin grafted into the defect site. Group 2: Ten patients will be treated the simplified papilla preservation flap with laser therapy performed into the defect site. The laser used in the study is diode lasers (940nm), with an output power of 3 W in the contact mode.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nashwa Helaly Mohamed, Assiut University
- Investigators
- Ahmed Mortada Fikry, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641739
- Sponsor's protocol ID
- laser and PRF in periodontitis
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Trials of Laser Photobiomodulation and Platelets Rich in Growth Factors (PRGFs)-Assisted Flap Surgery in Treating Stage III Periodontal Defects: an In-Depth Analysis of Clinical Outcomes and Healing Processes
- ClinicalTrials.gov ID
- NCT06641739
- Acronym / sponsor ID
- laser and PRF in periodontitis
- Conditions
- Periodontal Diseases
- Keywords
- photobiomodulation, laser therapy, PRF, stage III periodontal diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 5 Feb 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
Stage 3 periodontitis is a condition marked by swift and severe destruction of periodontal tissues. To effectively regenerate osseous defects resulting from periodontal disease, it is crucial to leverage the intrinsic regenerative potential of the periodontium via meticulously formulated therapeutic strategies
Detailed description
The main treatment methods of periodontal diseases involve scaling and root planning (SRP), and periodontal surgery. Periodontopathogens, can penetrate deep by crossing the epithelial barrier which may be difficult to be remove by nonsurgical periodontal therapy (NSPT) alone. A multitude of grafted and non-grafted approaches have been used in the management of Intra-bony defects. However, they do not provide predictable periodontal regeneration.
A systematic review on the use of platelet-rich fibrin (PRF) for managing periodontal defects highlights its promising potential in periodontal regeneration. It forms a fibrin matrix that promotes angiogenesis and enhances healing at defected sites. The review emphasizes PRF's ability to sustain the release of growth factors, which are crucial for osteoblastic proliferation, migration, and adherence. This makes PRF an effective scaffold for cellular elements, facilitating periodontal tissue regeneration.
Laser photobiomodulation (PBM) has emerged as a promising adjunctive treatment as it stimulates cellular processes, enhancing the natural regenerative capabilities of periodontal tissues. Recent studies have demonstrated that PBM, particularly with diode, significantly improves clinical outcomes when combined with conventional periodontal treatments. It promotes osteoblastic proliferation, migration, and adherence, thereby facilitating bone regeneration and reducing periodontal pocket depth. Additionally, PBM enhances angiogenesis and modulates the release of growth factors, creating an optimal healing environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: Ten patients will be treated with simplified papilla preservation flap with platelet-rich fibrin grafted into the defect site. Group 2: Ten patients will be treated the simplified papilla preservation flap with laser therapy performed into the defect site. The laser used in the study is diode lasers (940nm), with an output power of 3 W in the contact mode.
| Arm | Type | Receives |
|---|---|---|
| • Laser-treated group | Active comparator | Device: laser assisted SPPFTen patients will be treated the simplified papilla preservation flap with laser therapy performed into the defect site. The laser used in the study is diode lasers ( 940nm), with an output power of 3 W in the contact mode. |
| platelets Rich Fibrin Graft | Active comparator | Procedure: Platelet Rich PlasmaTen patients will be treated with simplified papilla preservation flap with platelet-rich fibrin grafted into the defect site. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with PPD =5 mm and clinical attachment loss of ≥3 mm;
- Presence of 2 walled or 3 walled infra-bony defects posterior segments;
- Evidence of ≥3 mm of intra-bony defect depth evaluated by the visualization of peri-apical radiographs.
Key exclusion criteria (5 listed)
- Patients requiring antibiotic prophylaxis before the periodontal examination;
- Patients diagnosed with malocclusion at the site of the defect;
- Patients with systemic disease and/or on drugs that contraindicate periodontal surgery;
- Patients with a history of smoking and pan chewing;
- Sites with advanced class II \& III furcation involvement.
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 |
|---|---|---|
| laser assisted SPPFA full-thickness flaps were elevated. In the test sites after the SPPF access will be performed, root surface debridement will be meticulously performed, followed by intra-marrow penetrations (IMPs), on the defect walls using a 0.25 mm wide half round bur, mounted on a slow-speed handpiece. Following this, low-level laser biostimulation of the defect will be effected with an 940 nm diode laser at 3 W power, with an uninitiated 0.6mm optical fiber tip. The defects will be irradiated for 20 seconds in a continuous noncontact mode and then retracted for 8 seconds. This will be repeated for 3 times so that the defects were effectively lased for about 60 seconds. | Device | • Laser-treated group |
| Platelet Rich PlasmaIn the second group, following the SPPF, the defect will grafted with particulated PRF, which will be overlaid with a PRF membrane, without any adjunctive defect management measures. PRF will be prepared by collecting Intra-venous blood (from the antecubital vein) in a 10-ml sterile glass tube without anticoagulant and immediately centrifuged in a centrifugation machine at 3000 rpm for 10 minutes. It will result in the separation of blood into a structured fibrin matrix in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma (platelet poor plasma) at the top. PPP will be discarded. PRF will be easily separated from the red corpuscles base using sterile tweezers and scissors. | Procedure or surgery | platelets Rich Fibrin Graft |
Primary outcome
-Evaluation of the changes in the clinical attachment loss
Time frame: [Time Frame: at base line, 1 month and 3 months after treatment]
Attachment level will be measured using UNC15(University of North Carolina) periodontal probe. Clinical attachment loss will be measured as the distance from the cemento-enamel junction to the base of the pocket.[Time Frame: at base line, 1 month and 3 months after treatment]
probing depth
Time frame: [Time Frame: at base line, 1 month and 3 months after treatment]
The measurement will be recorded by UNC15(University of North Carolina) periodontal probe . Pocket depth will be measured as the distances from the free gingival margin to the base of the periodontal pocket.
2 secondary outcomes
-Plaque index (PI)
Time frame: [Time Frame: at base line, 1 month and 3 months after treatment]
Gingival index (GI)
Time frame: [Time Frame: at base line, 1 month and 3 months after treatment]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- reatment of 3-wall intrabony defects in patients with chronic periodontitis with autologous platelet-rich fibrin: A randomized controlled clinical trial. JLink provided by the sponsor.
- Clinical significance of non-surgical periodontal therapy: an evidence-based perspective of scaling and root planingLink provided by the sponsor.
- Regeneration of periodontal intrabony defects using platelet-rich fibrin (PRF): A systematic review and network meta-analysis. OdontologyLink provided by the sponsor.
- Strategies of cell and cell-free therapies for periodontal regeneration: the state of the art.Link provided by the sponsor.
- 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.
Ahmed Mortada Fikry, professor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing laser assisted SPPF and Platelet Rich Plasma in people with Periodontal Diseases, run by Assiut University.
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 3 inclusion and 5 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 15 Oct 2024. 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?
Contact Nashwa Helaly Mohamed, lecturer (+2001002226405, nashwahelaly@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-Evaluation of the changes in the clinical attachment loss (time frame: [Time Frame: at base line, 1 month and 3 months after treatment]). The study lists 2 primary outcomes in all. 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 Oct 2024.