Trial Outcomes & Findings for Comparison of Two Different Types of Platelet Concentrate to Augment Bone Around Immediate Dental Implant (NCT NCT05595772)
NCT ID: NCT05595772
Last Updated: 2026-06-09
Results Overview
evaluation of bone density around immediate implants as (D1,D2,D3,D4)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
9 months
Results posted on
2026-06-09
Participant Flow
Participant milestones
| Measure |
Group A (Concentrated Growth Factor) CGF
ten patients indicated for immediate implant in the maxillary anterior region (class II socket)
Drug: Growth Factors (CGF): Application of biological membrane of Concentrated growth factor (CGF) over bone grafting and implant
Surgery: Dental Implant surgery: Immediate implant following extraction
Tooth extraction: A Traumatic tooth extraction
Xenogenic bone grafting: Application of bovine bone grafting over area of dehiscence around immediate implant
|
Group B (Plasma Rich in Growth Factor) PRGF
Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket),
Drug: Growth Factors (PRGF): Application of biological membrane of Plasma rich in growth factors combined with Xenogeneic bone grafting material around immediate implant
Surgery: Dental Implant surgery: Immediate implant following extraction
Tooth extraction: A Traumatic tooth extraction
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Different Types of Platelet Concentrate to Augment Bone Around Immediate Dental Implant
Baseline characteristics by cohort
| Measure |
Group A (Concentrated Growth Factor) CGF
n=10 Participants
Ten patients indicated for immediate implant in the maxillary anterior region (class II socket)
Drug: Growth Factors (CGF): Application of biological membrane of Concentrated growth factor (CGF) over bone grafting and implant
Surgery: Dental Implant surgery: Immediate implant following extraction
Tooth extraction: A Traumatic tooth extraction
Xenogenic bone grafting: Application of bovine bone grafting over area of dehiscence around immediate implant
|
Group B (Plasma Rich in Growth Factor) PRGF
n=10 Participants
Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket),
Drug: Growth Factors (PRGF): Application of biological membrane of Plasma rich in growth factors combined with Xenogeneic bone grafting material around immediate implant
Surgery: Dental Implant surgery: Immediate implant following extraction
Tooth extraction: A Traumatic tooth extraction
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.70 years
STANDARD_DEVIATION 6.71 • n=20 Participants
|
30.80 years
STANDARD_DEVIATION 7.28 • n=20 Participants
|
30.25 years
STANDARD_DEVIATION 6.995 • n=40 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Bone Density
|
483.9 Hounsfield
STANDARD_DEVIATION 246.1 • n=20 Participants
|
787.2 Hounsfield
STANDARD_DEVIATION 422.0 • n=20 Participants
|
635.55 Hounsfield
STANDARD_DEVIATION 154.48 • n=40 Participants
|
|
Marginal bone level
|
2.68 millimeter
STANDARD_DEVIATION 0.52 • n=20 Participants
|
2.23 millimeter
STANDARD_DEVIATION 0.77 • n=20 Participants
|
2.455 millimeter
STANDARD_DEVIATION 0.645 • n=40 Participants
|
PRIMARY outcome
Timeframe: 9 monthsevaluation of bone density around immediate implants as (D1,D2,D3,D4)
Outcome measures
| Measure |
Group A (Concentrated Growth Factor) CGF
n=10 Participants
ten patients indicated for immediate implant in the maxillary anterior region (class II socket)
Drug: Growth Factors (CGF): Application of biological membrane of Concentrated growth factor (CGF) over bone grafting and implant
Surgery: Dental Implant surgery: Immediate implant following extraction
Tooth extraction: A Traumatic tooth extraction
Xenogenic bone grafting: Application of bovine bone grafting over area of dehiscence around immediate implant
|
Group B (Plasma Rich in Growth Factor) PRGF
n=10 Participants
Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket),
Drug: Growth Factors (PRGF): Application of biological membrane of Plasma rich in growth factors combined with Xenogeneic bone grafting material around immediate implant
Surgery: Dental Implant surgery: Immediate implant following extraction
Tooth extraction: A Traumatic tooth extraction
|
|---|---|---|
|
Bone Density
|
660.3 Hounsfield
Standard Deviation 250.8
|
959.2 Hounsfield
Standard Deviation 360.3
|
PRIMARY outcome
Timeframe: 9 monthsevaluation of marginal bone level around implant in comparison with baseline bone level immediately after surgery using a fixed point on CBCT
Outcome measures
| Measure |
Group A (Concentrated Growth Factor) CGF
n=10 Participants
ten patients indicated for immediate implant in the maxillary anterior region (class II socket)
Drug: Growth Factors (CGF): Application of biological membrane of Concentrated growth factor (CGF) over bone grafting and implant
Surgery: Dental Implant surgery: Immediate implant following extraction
Tooth extraction: A Traumatic tooth extraction
Xenogenic bone grafting: Application of bovine bone grafting over area of dehiscence around immediate implant
|
Group B (Plasma Rich in Growth Factor) PRGF
n=10 Participants
Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket),
Drug: Growth Factors (PRGF): Application of biological membrane of Plasma rich in growth factors combined with Xenogeneic bone grafting material around immediate implant
Surgery: Dental Implant surgery: Immediate implant following extraction
Tooth extraction: A Traumatic tooth extraction
|
|---|---|---|
|
Marginal Bone Level.
|
1.97 millimeter
Standard Deviation 0.44
|
1.16 millimeter
Standard Deviation 0.47
|
Adverse Events
Group A (Concentrated Growth Factor) CGF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B (Plasma Rich in Growth Factor) PRGF
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A (Concentrated Growth Factor) CGF
n=10 participants at risk
ten patients indicated for immediate implant in the maxillary anterior region (class II socket)
Drug: Growth Factors (CGF): Application of biological membrane of Concentrated growth factor (CGF) over bone grafting and implant
Surgery: Dental Implant surgery: Immediate implant following extraction
Tooth extraction: A Traumatic tooth extraction
Xenogenic bone grafting: Application of bovine bone grafting over area of dehiscence around immediate implant
|
Group B (Plasma Rich in Growth Factor) PRGF
n=10 participants at risk
Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket),
Drug: Growth Factors (PRGF): Application of biological membrane of Plasma rich in growth factors combined with Xenogeneic bone grafting material around immediate implant
Surgery: Dental Implant surgery: Immediate implant following extraction
Tooth extraction: A Traumatic tooth extraction
|
|---|---|---|
|
Blood and lymphatic system disorders
hemorrhage
|
0.00%
0/10 • 9 months
the surgery was done under local anasthesia, senstivity test was done preoperatively patients were subjected to detailed history taking to assure excluding of patients with present illness or immunocompromised status all steps were done in hospital
|
0.00%
0/10 • 9 months
the surgery was done under local anasthesia, senstivity test was done preoperatively patients were subjected to detailed history taking to assure excluding of patients with present illness or immunocompromised status all steps were done in hospital
|
|
Nervous system disorders
Nerve damage
|
0.00%
0/10 • 9 months
the surgery was done under local anasthesia, senstivity test was done preoperatively patients were subjected to detailed history taking to assure excluding of patients with present illness or immunocompromised status all steps were done in hospital
|
0.00%
0/10 • 9 months
the surgery was done under local anasthesia, senstivity test was done preoperatively patients were subjected to detailed history taking to assure excluding of patients with present illness or immunocompromised status all steps were done in hospital
|
|
Surgical and medical procedures
violation of maxillary sinus
|
0.00%
0/10 • 9 months
the surgery was done under local anasthesia, senstivity test was done preoperatively patients were subjected to detailed history taking to assure excluding of patients with present illness or immunocompromised status all steps were done in hospital
|
0.00%
0/10 • 9 months
the surgery was done under local anasthesia, senstivity test was done preoperatively patients were subjected to detailed history taking to assure excluding of patients with present illness or immunocompromised status all steps were done in hospital
|
Other adverse events
| Measure |
Group A (Concentrated Growth Factor) CGF
n=10 participants at risk
ten patients indicated for immediate implant in the maxillary anterior region (class II socket)
Drug: Growth Factors (CGF): Application of biological membrane of Concentrated growth factor (CGF) over bone grafting and implant
Surgery: Dental Implant surgery: Immediate implant following extraction
Tooth extraction: A Traumatic tooth extraction
Xenogenic bone grafting: Application of bovine bone grafting over area of dehiscence around immediate implant
|
Group B (Plasma Rich in Growth Factor) PRGF
n=10 participants at risk
Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket),
Drug: Growth Factors (PRGF): Application of biological membrane of Plasma rich in growth factors combined with Xenogeneic bone grafting material around immediate implant
Surgery: Dental Implant surgery: Immediate implant following extraction
Tooth extraction: A Traumatic tooth extraction
|
|---|---|---|
|
Blood and lymphatic system disorders
postoperative bleeding
|
0.00%
0/10 • 9 months
the surgery was done under local anasthesia, senstivity test was done preoperatively patients were subjected to detailed history taking to assure excluding of patients with present illness or immunocompromised status all steps were done in hospital
|
0.00%
0/10 • 9 months
the surgery was done under local anasthesia, senstivity test was done preoperatively patients were subjected to detailed history taking to assure excluding of patients with present illness or immunocompromised status all steps were done in hospital
|
|
Surgical and medical procedures
postoperative swelling
|
0.00%
0/10 • 9 months
the surgery was done under local anasthesia, senstivity test was done preoperatively patients were subjected to detailed history taking to assure excluding of patients with present illness or immunocompromised status all steps were done in hospital
|
10.0%
1/10 • Number of events 1 • 9 months
the surgery was done under local anasthesia, senstivity test was done preoperatively patients were subjected to detailed history taking to assure excluding of patients with present illness or immunocompromised status all steps were done in hospital
|
Additional Information
DR. Hussein fathy
Minia university, faculty of dentistry
Phone: +201092452350
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place