PeriodontitisPhase 2/3NCT06153706
Evaluation of L-PRF as an Antibiotic Slow-release Biological Device in the Treatment of Moderate Periodontitis
A Phase 2/3 study testing Subgingival application of L-PRF loaded with metronidazole and Subgingival application of L-PRF in people with Periodontitis, run by Yasmeen Khaled at 1 site in Egypt.
Trial summary
This study aimed to evaluate the efficacy of leukocyte platelet-rich fibrin (L-PRF) as a local sustained released device for antibiotics. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Subgingival application of L-PRF loaded with metronidazole and Subgingival application of L-PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Oct 2023
- Phase
- Phase 2/3
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients suffering from stage II periodontitis with probing depth and exhibiting bleeding on probing.
- Patients showing good oral hygiene.
- No history of periodontal therapy (surgical and non-surgical) for the past 6 months.
Who cannot join
- Patients with known systemic and debilitating diseases.
- Patients who had any previous adverse reactions to the products (or similar products) used in this study.
- Patients who have any autoimmune diseases.
- Patients who have any known disease that interfere with periodontal procedure.
- Smokers.
- Pregnancy and lactating women.
- Use of antibiotics during the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of L-PRF as an Antibiotic Slow-release Biological Device in the Treatment of Moderate Periodontitis (A Randomized Controlled Clinical Trial)
This study aimed to evaluate the efficacy of leukocyte platelet-rich fibrin (L-PRF) as a local sustained released device for antibiotics.
- Conditions
- Periodontitis
- Being tested
- Subgingival application of L-PRF loaded with metronidazole, Subgingival application of L-PRF
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subgingival application of L-PRF loaded with metronidazoleDrug
After phase I therapy, L-PRF loaded medical grade metronidazole was applied sub gingivally into the pockets using blunt gauge needle and Perio-pack was placed (two applications with one week apart were applied subgingivally.
Subgingival application of L-PRFOther
The L-PRF alone was applied subgingivally into the pockets and Perio-pack was placed (two applications with one week apart.
| Study group | Role | What they receive |
|---|---|---|
| L-PFR loaded with medical grade metronidazole | Experimental | Not described Receives: Drug: Subgingival application of L-PRF loaded with metronidazole |
| L-PFR | Active comparator | Not described Receives: Other: Subgingival application of L-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque accumulation
This was assessed using O'Leary plaque index which is based on the visible continuous plaque along the gingival margin after staining. Four or six sites per tooth were examined, and the percentage of tooth surfaces exhibiting stained plaque was calculated. The score ranges from 0% (no plaque) to 100% (abundant plaque)
Measured: up to 6 months
Gingival inflammation
This was assessed using modified gingival index which uses a visual scale to assess gingival health. It relies on a visual assessment of gingival changes to measure the severity of inflammation. Five categories, using a 0-4 scale, score the marginal and papillary gingival tissue based on color, texture, edema, and spontaneous bleeding. Using this index, 108 sites are scored per person (52 papillary and 56 marginal sites). Score 0 indicates normal gingival, score 1: mild inflammation with slight changes in color and texture, but not in all portions of gingival marginal or papillary, score 2: Mild inflammation with slight changes in color and texture in all portions of gingival marginal or papillary, score 3: Moderate bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary, and score 4: Severe inflammation with erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration
Measured: up to 6 months
Bleeding on probing
This was assessed using bleeding index which assesses bleeding on probing. The number of sites where bleeding is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the bleeding index as a percentage. The score ranges from 0% (no bleeding) to 100% (bleeding in all sites)
Measured: up to 6 months
Probing depth
The distance measured (mm) using a periodontal probe from the base of the pocket to the most apical point on the gingival margin. It dictates the patient's ability to maintain optimal plaque control. Probing depths in excess of 3mm are an indication for periodontal therapy.
Measured: up to 6 months
Clinical attachment loss
It represents the extent of periodontal support that has been lost around a tooth and is measured with the periodontal probe as the distance (mm) from the cemento-enamel junction to the base of the pocket
Measured: up to 6 months
Quantitative assessment of Porhyromonas gingivalis
Relative quantitation of Porhyromonas gingivalis counts was performed by Real Time PCR. Subgingival plaque samples were calculated, DNA was isolated and quantified for standardizing the polymerase chain reaction.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Jun 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasmeen Khaled
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasmeen Khaled, Alexandria University
- Investigators
- Yasmeen K Omar, BDS, Principal investigator, Alexandria UniversityMohy A El Rashidy, PhD, Study director, Alexandria UniversityGhada Bassiouny, PhD, Study chair, Alexandria UniversityAliaa G Aboulela, PhD, Study chair, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153706
- Sponsor's protocol ID
- #6/22
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Omar YK, Rashidy MAE, Ahmed GB, Aboulela AG. Evaluation of leukocyte-platelet rich fibrin as an antibiotic slow-release biological device in the treatment of moderate periodontitis: a randomized controlled clinical trial. BMC Oral Health. 2024 Dec 21;24(1):1530. doi: 10.1186/s12903-024-05254-x.
PubMed 39709402
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of L-PRF as an Antibiotic Slow-release Biological Device in the Treatment of Moderate Periodontitis (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06153706
- Acronym / sponsor ID
- #6/22
- Conditions
- Periodontitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yasmeen KhaledUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 1 Dec 2023 (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 aimed to evaluate the efficacy of leukocyte platelet-rich fibrin (L-PRF) as a local sustained released device for antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-PFR loaded with medical grade metronidazole | Experimental | Drug: Subgingival application of L-PRF loaded with metronidazole |
| L-PFR | Active comparator | Other: Subgingival application of L-PRF |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients suffering from stage II periodontitis with probing depth and exhibiting bleeding on probing.
- Patients showing good oral hygiene.
- No history of periodontal therapy (surgical and non-surgical) for the past 6 months.
Key exclusion criteria (7 listed)
- Patients with known systemic and debilitating diseases.
- Patients who had any previous adverse reactions to the products (or similar products) used in this study.
- Patients who have any autoimmune diseases.
- Patients who have any known disease that interfere with periodontal procedure.
- Smokers.
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 |
|---|---|---|
| Subgingival application of L-PRF loaded with metronidazoleAfter phase I therapy, L-PRF loaded medical grade metronidazole was applied sub gingivally into the pockets using blunt gauge needle and Perio-pack was placed (two applications with one week apart were applied subgingivally. | Drug | L-PFR loaded with medical grade metronidazole |
| Subgingival application of L-PRFThe L-PRF alone was applied subgingivally into the pockets and Perio-pack was placed (two applications with one week apart. | Other | L-PFR |
Primary outcome
Plaque accumulation
Time frame: up to 6 months
This was assessed using O'Leary plaque index which is based on the visible continuous plaque along the gingival margin after staining. Four or six sites per tooth were examined, and the percentage of tooth surfaces exhibiting stained plaque was calculated. The score ranges from 0% (no plaque) to 100% (abundant plaque)
Gingival inflammation
Time frame: up to 6 months
This was assessed using modified gingival index which uses a visual scale to assess gingival health. It relies on a visual assessment of gingival changes to measure the severity of inflammation. Five categories, using a 0-4 scale, score the marginal and papillary gingival tissue based on color, texture, edema, and spontaneous bleeding. Using this index, 108 sites are scored per person (52 papillary and 56 marginal sites). Score 0 indicates normal gingival, score 1: mild inflammation with slight changes in color and texture, but not in all portions of gingival marginal or papillary, score 2: Mild inflammation with slight changes in color and texture in all portions of gingival marginal or papillary, score 3: Moderate bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary, and score 4: Severe inflammation with erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration
Bleeding on probing
Time frame: up to 6 months
This was assessed using bleeding index which assesses bleeding on probing. The number of sites where bleeding is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the bleeding index as a percentage. The score ranges from 0% (no bleeding) to 100% (bleeding in all sites)
Probing depth
Time frame: up to 6 months
The distance measured (mm) using a periodontal probe from the base of the pocket to the most apical point on the gingival margin. It dictates the patient's ability to maintain optimal plaque control. Probing depths in excess of 3mm are an indication for periodontal therapy.
Clinical attachment loss
Time frame: up to 6 months
It represents the extent of periodontal support that has been lost around a tooth and is measured with the periodontal probe as the distance (mm) from the cemento-enamel junction to the base of the pocket
Quantitative assessment of Porhyromonas gingivalis
Time frame: up to 6 months
Relative quantitation of Porhyromonas gingivalis counts was performed by Real Time PCR. Subgingival plaque samples were calculated, DNA was isolated and quantified for standardizing the polymerase chain reaction.
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 Dec 2023.
- Derived from this study: PubMed 39709402Omar YK, Rashidy MAE, Ahmed GB, Aboulela AG. Evaluation of leukocyte-platelet rich fibrin as an antibiotic slow-release biological device in the treatment of moderate periodontitis: a randomized controlled clinical trial. BMC Oral Health. 2024 Dec 21;24(1):1530. doi: 10.1186/s12903-024-05254-x.
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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.
Yasmeen K Omar, BDS principal investigator
Alexandria University
Mohy A El Rashidy, PhD study director
Alexandria University
Ghada Bassiouny, PhD study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Subgingival application of L-PRF loaded with metronidazole and Subgingival application of L-PRF in people with Periodontitis, run by Yasmeen Khaled 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 3 inclusion and 7 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 Dec 2023. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Plaque accumulation (time frame: up to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06153706, which also lists 1 linked publication.
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 Dec 2023.