Periodontal Bone LossNCT05496608
Treatment of Intrabony Defects With L-PRF Membrane With or Without Collagen Membranes
A study testing L-PRF, OFD and CM in people with Periodontal Bone Loss and Periodontal Diseases, run by Future University in Egypt at 1 site in Egypt.
Trial summary
For patients having periodontal intrabony lesions, three treatment modalities were executed to evaluate the effect of protecting Leukocyte rich -Platelet Rich Fibrin harvests (applied in the bony defects) with resorbable collagen membranes. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Bone Loss, Periodontal Diseases
- What is being tested?
- L-PRF, OFD and CM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Feb 2022
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Minimum of one interproximal pocket probing depth of ≥6 mm and/or ≥5 mm CAL after 4 weeks from phase I execution
- 2 or 3 osseous wall interproximal intrabony defects that are ≥3mm in depth
Who cannot join
- Systemic diseases or conditions that contraindicate periodontal surgeries and/or affect the formed elements of the blood
- Patients who received antibiotic therapy and/or anti-inflammatory drug within the past 6 months
- Vulnerable groups
- Interdental craters and 1 wall osseous defects
- Active periapical pathosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Periodontal Intrabony Defects With Dense Leukocyte and Platelet-Rich Fibrin (L-PRF) Membrane Alone or in Combination With Collagen Membranes (Randomized Clinical and Biochemical Trial)
For patients having periodontal intrabony lesions, three treatment modalities were executed to evaluate the effect of protecting Leukocyte rich -Platelet Rich Fibrin harvests (applied in the bony defects) with resorbable collagen membranes. Clinical Outcomes recorded were the Plaque index (PI), Gingival index (GI), probing depth reduction (PD), Clinical attachment level (CAL), and radiographic defect depth changes.
For the biochemical evaluation: levels of PDGF-BB and VEGF obtained from crevicular fluid by Perio-Paper strips were assessed using ELIZA.
Read the detailed description
- Patients having 2-3 osseous bony wall infrabony periodontal lesions are enrolled in the present study. They have to be free from any systemic disease that contraindicates periodontal surgeries.
- Baseline data are obtained including the GI, PI, PD, CAL and preoperative paralleling periapical radiographs.
- Full thickness mucoperiosteal flaps are elevated and thorough debridement of the periodontal bony defect is performed.
- for OFD group; following debridement and saline irrigation, wound closure proceeds.
- for the L-PRF group; L-PRF is prepared and applied within the defect before primary closure.
- for the L-PRF + CM: similar procedure like the second group is performed but with an additional protective layer of collagen membrane on top of the defect before wound closure.
- from the second day postoperative; Periopaper strips are used to obtain a crevicular fluid sample from the sulcus
- At 6 months postoperative: the same baseline clinical measurements are obtained.
- Conditions
- Periodontal Bone Loss, Periodontal Diseases
- Being tested
- L-PRF, OFD, CM
- Medical subject headings
- Alveolar Bone Loss, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-PRFProcedure or surgery
Also called Leukocyte platelet rich fibrin
a blood sample is obtained from the patient, and centrifuged to prepare a leukocyte platelet rich fibrin harvest that is applied within the derided lesion.
OFDProcedure or surgery
Also called Open flap Debridement
Full thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure.
CMProcedure or surgery
Also called Collagen membrane
Xenogeneic collagen membranes that are used as barrier membranes in guided tissue regeneration of periodontal defects
| Study group | Role | What they receive |
|---|---|---|
| Open Flap Debridement | Placebo comparator | Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion Receives: Procedure: OFD |
| L-PRF | Active comparator | Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion followed by application of the L-PRF within the bony defect Receives: Procedure: L-PRF; Procedure: OFD |
| L-PRF + CM | Active comparator | Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion followed by application of the L-PRF within the bony defect and coverage with collagen xenogeneic membrane Receives: Procedure: L-PRF; Procedure: OFD; Procedure: CM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival index
measures the score of gingival inflammation. Minimum value of 0: denotes absence of inflammation. Maximum value = 3 and denotes severe inflammation
Measured: 6 months
Plaque index
measures the score of plaque accumulation. Minimum value of 0: denotes absence of plaque on teeth surfaces. Maximum value = 3 and denotes diffuse and abundant plaque accumulation on teeth surfaces
Measured: 6 months
Probing depth
measures the reduction in pocket depth
Measured: 6 months
Clinical attachment level
measures the changes in amount of periodontal attachment
Measured: 6 months
CEJ to base of defect
measures the changes in bone defect depth
Measured: 6 months
CEJ to alveolar crest
measures the amount of crystal bone changes
Measured: 6 months
Secondary outcomes (2)
PDGF
Biochemical Evaluation of changes in levels of crevicular Platelet Derived Growth Factor -BB
Measured: 31 days
VEGF
Biochemical Evaluation of changes in levels of crevicular Vascular endothelial growth factor
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Jan 2021
- Primary completion30 Nov 2021
- Study completion1 Feb 2022
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 Periodontal Bone LossStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy Mubarak Hussein, Future University in Egypt
- Investigators
- Ahmed Gamal, P.H.D, Study chair, Professor of periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496608
- Sponsor's protocol ID
- Ainshams University
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mubarak R, Adel-Khattab D, Abdel-Ghaffar KA, Gamal AY. Adjunctive effect of collagen membrane coverage to L-PRF in the treatment of periodontal intrabony defects: a randomized controlled clinical trial with biochemical assessment. BMC Oral Health. 2023 Sep 4;23(1):631. doi: 10.1186/s12903-023-03332-0.
PubMed 37667213
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Periodontal Intrabony Defects With Dense Leukocyte and Platelet-Rich Fibrin (L-PRF) Membrane Alone or in Combination With Collagen Membranes (Randomized Clinical and Biochemical Trial)
- ClinicalTrials.gov ID
- NCT05496608
- Acronym / sponsor ID
- Ainshams University
- Conditions
- Periodontal Bone Loss, Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 11 Aug 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.
For patients having periodontal intrabony lesions, three treatment modalities were executed to evaluate the effect of protecting Leukocyte rich -Platelet Rich Fibrin harvests (applied in the bony defects) with resorbable collagen membranes. Clinical Outcomes recorded were the Plaque index (PI), Gingival index (GI), probing depth reduction (PD), Clinical attachment level (CAL), and radiographic defect depth changes.
For the biochemical evaluation: levels of PDGF-BB and VEGF obtained from crevicular fluid by Perio-Paper strips were assessed using ELIZA.
Detailed description
- Patients having 2-3 osseous bony wall infrabony periodontal lesions are enrolled in the present study. They have to be free from any systemic disease that contraindicates periodontal surgeries.
- Baseline data are obtained including the GI, PI, PD, CAL and preoperative paralleling periapical radiographs.
- Full thickness mucoperiosteal flaps are elevated and thorough debridement of the periodontal bony defect is performed.
- for OFD group; following debridement and saline irrigation, wound closure proceeds.
- for the L-PRF group; L-PRF is prepared and applied within the defect before primary closure.
- for the L-PRF + CM: similar procedure like the second group is performed but with an additional protective layer of collagen membrane on top of the defect before wound closure.
- from the second day postoperative; Periopaper strips are used to obtain a crevicular fluid sample from the sulcus
- At 6 months postoperative: the same baseline clinical measurements are obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Flap Debridement | Placebo comparator | Procedure: OFDSubjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion |
| L-PRF | Active comparator | Procedure: L-PRF, Procedure: OFDSubjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion followed by application of the L-PRF within the bony defect |
| L-PRF + CM | Active comparator | Procedure: L-PRF, Procedure: OFD, Procedure: CMSubjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion followed by application of the L-PRF within the bony defect and coverage with collagen xenogeneic membrane |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Minimum of one interproximal pocket probing depth of ≥6 mm and/or ≥5 mm CAL after 4 weeks from phase I execution
- 2 or 3 osseous wall interproximal intrabony defects that are ≥3mm in depth
Key exclusion criteria (5 listed)
- Systemic diseases or conditions that contraindicate periodontal surgeries and/or affect the formed elements of the blood
- Patients who received antibiotic therapy and/or anti-inflammatory drug within the past 6 months
- Vulnerable groups
- Interdental craters and 1 wall osseous defects
- Active periapical pathosis
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 |
|---|---|---|
| L-PRFAlso: Leukocyte platelet rich fibrina blood sample is obtained from the patient, and centrifuged to prepare a leukocyte platelet rich fibrin harvest that is applied within the derided lesion. | Procedure or surgery | L-PRF, L-PRF + CM |
| OFDAlso: Open flap DebridementFull thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure. | Procedure or surgery | L-PRF, L-PRF + CM, Open Flap Debridement |
| CMAlso: Collagen membraneXenogeneic collagen membranes that are used as barrier membranes in guided tissue regeneration of periodontal defects | Procedure or surgery | L-PRF + CM |
Primary outcome
Gingival index
Time frame: 6 months
measures the score of gingival inflammation. Minimum value of 0: denotes absence of inflammation. Maximum value = 3 and denotes severe inflammation
Plaque index
Time frame: 6 months
measures the score of plaque accumulation. Minimum value of 0: denotes absence of plaque on teeth surfaces. Maximum value = 3 and denotes diffuse and abundant plaque accumulation on teeth surfaces
Probing depth
Time frame: 6 months
measures the reduction in pocket depth
Clinical attachment level
Time frame: 6 months
measures the changes in amount of periodontal attachment
CEJ to base of defect
Time frame: 6 months
measures the changes in bone defect depth
CEJ to alveolar crest
Time frame: 6 months
measures the amount of crystal bone changes
2 secondary outcomes
PDGF
Time frame: 31 days
VEGF
Time frame: 31 days
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 25 Aug 2022.
- Derived from this study: PubMed 37667213Mubarak R, Adel-Khattab D, Abdel-Ghaffar KA, Gamal AY. Adjunctive effect of collagen membrane coverage to L-PRF in the treatment of periodontal intrabony defects: a randomized controlled clinical trial with biochemical assessment. BMC Oral Health. 2023 Sep 4;23(1):631. doi: 10.1186/s12903-023-03332-0.
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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 Gamal, P.H.D study chair
Professor of periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-PRF, OFD and CM in people with Periodontal Bone Loss and Periodontal Diseases, run by Future University in Egypt 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 2 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: finished, as of the sponsor's last update on 25 Aug 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. 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.
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?
Gingival index (time frame: 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 NCT05496608, 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 25 Aug 2022.