Clinical trial NCT05492357: Effects of Recurrent Application of Liquid-PRF on Hard and Soft Tissues
Official title: The Effect of Recurrent Application of Liquid Platelet-rich Fibrin in the Extraction Socket on the Hard and Soft Tissues. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liquid-PRF
A-PRF Plus
Keywords: recurrent
Liquid platelet-rich fibrin
Advanced platelet-rich fibrin plus
ridge preservation
Lead sponsor: Arab American University (Palestine)
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Ridge dimensions
timeFrame: 3 months
measure: Gingival biotype
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: Palestinian Territory, occupied
facility: Cezar Lahham
Study officials:
References: