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

NCT05492357 | Completed DMC

• 1 other identifier: PHRC/HC/1151/22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liquid-PRF; A-PRF Plus

Keywords

recurrent; Liquid platelet-rich fibrin; Advanced platelet-rich fibrin plus; ridge preservation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Advanced platelet-rich fibrin plus + Liquid platelet-rich fibrin

EXPERIMENTAL

A-PRF plus + Liquid-PRF are prepared from the patient's blood.

Other: Liquid platelet-rich fibrin; Other: Advanced Platelet-rich fibrin plus

Advanced platelet-rich fibrin plus alone

EXPERIMENTAL

A-PRF+ is prepared from the patient's blood.

Other: Advanced Platelet-rich fibrin plus

Interventions

Liquid platelet-rich fibrin OTHER

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)

Also known as: Liquid-PRF

Advanced platelet-rich fibrin plus + Liquid platelet-rich fibrin

Advanced Platelet-rich fibrin plus OTHER

A-PRF+ is placed into the extraction socket immediately after tooth extraction

Advanced platelet-rich fibrin plus + Liquid platelet-rich fibrin; Advanced platelet-rich fibrin plus alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cezar Edward Lahham: lead

Study Sites (1)

Cezar Lahham

Bethlehem, 00000, Palestinian Territories

Location

Related Publications (1)

• Lahham C, Ta'a MA, Lahham E, Michael S, Zarif W. The effect of recurrent application of concentrated platelet-rich fibrin inside the extraction socket on the hard and soft tissues. a randomized controlled trial. BMC Oral Health. 2023 Sep 19;23(1):677. doi: 10.1186/s12903-023-03400-5.

  PMID: 37726689 DERIVED

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Human patients: 20 patients who need tooth/ teeth extraction would be selected according to the following 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 Record Dates

• First Submitted: August 1, 2022
• First Posted: August 8, 2022
• Study Start: June 15, 2022
• Primary Completion: August 15, 2022
• Study Completion: October 18, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)