Treatment of Intrabony Defects With L-PRF Membrane With or Without Collagen Membranes

Periodontal Diseases Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05496608
• Other study ID #: Ainshams University
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: August 2022
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: February 1, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Periodontal Bone Loss
• Periodontal Diseases

Intervention

Procedure:
• L-PRF
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.
• OFD
Full thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure.
• CM
Xenogeneic collagen membranes that are used as barrier membranes in guided tissue regeneration of periodontal defects

Locations

Country	Name	City	State
Egypt	Ainshams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival index	measures the score of gingival inflammation. Minimum value of 0: denotes absence of inflammation. Maximum value = 3 and denotes severe inflammation	6 months
Primary	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	6 months
Primary	Probing depth	measures the reduction in pocket depth	6 months
Primary	Clinical attachment level	measures the changes in amount of periodontal attachment	6 months
Primary	CEJ to base of defect	measures the changes in bone defect depth	6 months
Primary	CEJ to alveolar crest	measures the amount of crystal bone changes	6 months
Secondary	PDGF	Biochemical Evaluation of changes in levels of crevicular Platelet Derived Growth Factor -BB	31 days
Secondary	VEGF	Biochemical Evaluation of changes in levels of crevicular Vascular endothelial growth factor	31 days