Effects of Recurrent Application of Liquid-PRF on Hard and Soft Tissues (Liquid-PRF)

The Effect of Recurrent Application of Liquid Platelet-rich Fibrin in the Extraction Socket on the Hard and Soft Tissues. A Randomised Controlled Trial

Procedure: Tooth is extracted, then A-PRF+ is placed inside the socket. After that the ridge dimensions is asses clinically at the baseline) in addition to clinical assessment of the gingival biotype at the baseline.

Then patients will be divided into 2 groups:

Group 1: 50% of patients will have recurrent Liquid-PRF injections inside the extraction socket every 2 weeks (A-PRF+, followed by recurrent Liquid-PRF) Group 2: 50% of patients without recurrent (just A-PRF+) After 3 months from extraction: both groups will be assessed clinically (gingival biotype) & (Ridge dimensions) in order to assess the role of recurrent application of Liquid-PRF on these parameters.

Study Overview

• Status: Completed
• Conditions: Liquid-PRF; A-PRF Plus
• Intervention / Treatment: Other: Liquid platelet-rich fibrin; Other: Advanced Platelet-rich fibrin plus

Detailed Description

In this study, we will select 20 patients who need a simple tooth extraction, then determine the gingival biotype, take a blood sample to prepare A-PRF+ (centrifugation of the patient's blood for 8 min at 1300 rpm using red caps tubes), then do the extraction. After that, A-PRF+ is prepared and inserted into the extraction socket, and sutured using horizontal mattress suturing technique.

After the clinical assessment of the ridge dimensions at the baseline

Then patients will be divided into 2 groups:

Group 1: 10 patients will have recurrent Liquid-PRF injections inside the extraction socket every 2 weeks (A-PRF+, followed by recurrent Liquid-PRF) Liquid-PRF preparation: Centrifugation of the patient's blood for 8 min at 2500 rpm using white caps tubes.

Group 2: 10 patients without recurrent application of Liquid-PRF (just A-PRF+) After 3 months from extraction: both groups will be assessed clinically (gingival biotype) & (Ridge dimensions) in order to evaluate the effect of recurrent application of Liquid-PRF on these parameters.

Assessment method:

for Hard tissue evaluation (Bone): we assess the dimensions clinically For soft tissue: we will use a periodontal probe to assess the gingival thickness after giving local anesthesia.

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Selection Criteria

INCLUSION CRITERIA:

1. Men and women over 18 years of age
2. Indication of a simple extraction
3. Delivery of signed informed consent

EXCLUSION CRITERIA:

1. Need for multiple extractions
2. Presence of severe swelling prior to surgery in the extraction area
3. Regular treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs
4. Presence of hematologic disease
5. Previous radiation, chemotherapy, or immunosuppressive treatments
6. Uncontrolled diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Palestinian Territory, occupied
  • Bethlehem, Palestinian Territory, occupied, 00000
    • Cezar Lahham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men and women over 18 years of age
2. Indication of a simple extraction (Non-molar tooth)
3. Delivery of signed informed consent
4. Need delayed implant placement in the place of extraction

Exclusion Criteria:

1. Need for multiple extractions
2. Presence of severe swelling prior to surgery in the extraction area
3. Regular treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs
4. Presence of hematologic disease
5. Previous radiation, chemotherapy, or immunosuppressive treatments
6. Uncontrolled diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Advanced platelet-rich fibrin plus + Liquid platelet-rich fibrin; A-PRF plus + Liquid-PRF are prepared from the patient's blood.	Other: Liquid platelet-rich fibrin; Liquid platelet-rich fibrin is prepared from the patient's blood and injected into the extraction socket every two weeks (up to 3 months = Just 4 times of application); Other Names: Liquid-PRF; Other: Advanced Platelet-rich fibrin plus; A-PRF+ is placed into the extraction socket immediately after tooth extraction
Experimental: Advanced platelet-rich fibrin plus alone; A-PRF+ is prepared from the patient's blood.	Other: Advanced Platelet-rich fibrin plus; A-PRF+ is placed into the extraction socket immediately after tooth extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ridge dimensions	assessment of ridge dimensions 3 months after intervention for both groups. At the baseline it was assessed clinically. After 3 months, the flap was released and the ridge width and height were assessed clinically.	3 months
Gingival biotype	assessment of gingival biotype 3 months after intervention according to gingival thickness (using periodontal probe: if <1 mm = Thin, while if >1 =Thick).	3 months

Collaborators and Investigators

• Sponsor: Cezar Edward Lahham

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): October 18, 2022

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 5, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: recurrent; ridge preservation; Liquid platelet-rich fibrin; Advanced platelet-rich fibrin plus
• Other Study ID Numbers: PHRC/HC/1151/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No