Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-01-04 @ 1:28 PM
Study NCT ID:
NCT05492357
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2022-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Recurrent Application of Liquid-PRF on Hard and Soft Tissues
Sponsor:
Cezar Edward Lahham
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Liquid-PRF
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.
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.
\---------------------------------------------
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
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.
\---------------------------------------------
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: