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

NCT ID: NCT05492357

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2022-10-18

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.

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

Conditions

Liquid-PRF; A-PRF Plus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Liquid platelet-rich fibrin

Intervention Type: 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)

Advanced Platelet-rich fibrin plus

Intervention Type: OTHER

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

Advanced platelet-rich fibrin plus alone

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

Group Type: EXPERIMENTAL

Advanced Platelet-rich fibrin plus

Intervention Type: OTHER

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

Interventions

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)

Intervention Type: OTHER

Advanced Platelet-rich fibrin plus

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

Intervention Type: OTHER

Other Intervention Names

Liquid-PRF

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cezar Edward Lahham

OTHER

Sponsor Role: lead

Responsible Party

Cezar Edward Lahham

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cezar Lahham

Bethlehem, , Palestinian Territories

Countries

Palestinian Territories

References

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.

Reference Type: DERIVED

PMID: 37726689 (View on PubMed)

Other Identifiers

PHRC/HC/1151/22

Identifier Type: -

Identifier Source: org_study_id