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

• Sponsor: Cezar Edward Lahham (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05492357
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

Procedure: Tooth is extracted, then A-PRF is placed inside the socket. After that CBCT is done immediately (to assess the ridge dimensions 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 i-PRF injections inside the extraction socket every 2 weeks (A-PRF, followed by recurrent i-PRF) Group 2: 50% of patients without recurrent (just A-PRF) After 3 months from extraction: both groups will be assessed clinically (gingival biotype) & radiologically (Ridge dimensions) in order to assess the role of recurrent application of i-PRF on these parameters.

Condition or Disease	Intervention/Treatment	Phase
i-PRF; A-PRF	Other: injectable platelet-rich fibrin; Other: Advanced Platelet-rich fibrin	N/A

Detailed Description

In this study, we will select 40 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 14 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 that CBCT is done immediately (to assess the ridge dimensions at the baseline).

Then patients will be divided into 2 groups:

Group 1: 20 patients will have recurrent i-PRF injections inside the extraction socket every 2 weeks (A-PRF, followed by recurrent i-PRF) i-PRF preparation: Centrifugation of the patient's blood for 3 min at 700 rpm using white caps tubes.

Group 2: 20 patients without recurrent application of i-PRF (just A-PRF) After 3 months from extraction: both groups will be assessed clinically (gingival biotype) & radiologically (Ridge dimensions) in order to evaluate the effect of recurrent application of i-PRF on these parameters.

Assessment method:

for Hard tissue evaluation (Bone): we will use an Image fusion application (CBCT application).

For soft tissue: we will use a periodontal probe to assess the gingival thickness after giving local anesthesia.

---

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Human patients: 40 patients who need tooth/ teeth extraction would be selected according to the following criteria: INCLUSION CRITERIA: Men and women over 18 years of age Indication of a simple extraction Delivery of signed informed consent EXCLUSION CRITERIA: 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 pregnancyHuman patients:40 patients who need tooth/ teeth extraction would be selected according to the following criteria:INCLUSION CRITERIA:Men and women over 18 years of age Indication of a simple extraction Delivery of signed informed consentEXCLUSION CRITERIA: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
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical and Radiological Outcomes of Recurrent Application of Injectable Platelet-rich Fibrin in the Extraction Socket: A Randomized Controlled Trial
• Actual Study Start Date: Jun 15, 2022
• Anticipated Primary Completion Date: Aug 15, 2022
• Anticipated Study Completion Date: Dec 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Advanced platelet-rich fibrin + injectable platelet-rich fibrin A-PRF + i-PRF are prepared from the patient's blood.	Other: injectable platelet-rich fibrin; injectable 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: i-PRF ; Other: Advanced Platelet-rich fibrin; A-PRF is placed into the extraction socket immediately after tooth extraction
Experimental: Advanced platelet-rich fibrin alone A-PRF is prepared from the patient's blood.	Other: Advanced Platelet-rich fibrin; A-PRF is placed into the extraction socket immediately after tooth extraction

Outcome Measures

Primary Outcome Measures

1. Ridge dimensions [3 months]

   assessment of ridge dimensions 3 months after intervention for both groups using image fusion (CBCT application)

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cezar Lahham	Bethlehem		Palestinian Territory, occupied	00000

Sponsors and Collaborators

• Cezar Edward Lahham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cezar Edward Lahham, Principal Investigator, Arab American University (Palestine)
• ClinicalTrials.gov Identifier: NCT05492357
• Other Study ID Numbers: PHRC/HC/1151/22
• First Posted: Aug 8, 2022
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Cezar Edward Lahham, Principal Investigator, Arab American University (Palestine): recurrent; injectable platelet-rich fibrin; Advanced platelet-rich fibrin; ridge preservation

Study Results

No Results Posted as of Aug 8, 2022