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

Not Applicable

Completed

• Conditions: A-PRF Plus; Liquid-PRF

• Registration Number: NCT05492357
• Lead Sponsor: Cezar Edward Lahham

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

Study Timeline

• Study Start: 2022-06-15
• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Primary Completion: 2022-08-15
• Study Completion: 2022-10-18
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-05
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ridge dimensions	3 months	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.
Gingival biotype	3 months	assessment of gingival biotype 3 months after intervention according to gingival thickness (using periodontal probe: if \<1 mm = Thin, while if \>1 =Thick).

Trial Locations

Locations (1)

Cezar Lahham; 🇵🇸 Bethlehem, Palestinian Territory, occupied