Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT05608356
Status:
UNKNOWN
Last Update Posted:
2022-11-08
First Post:
2022-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Injectable Platelet-rich Fibrin on the En Masse Retraction of Maxillary Anterior Teeth
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Effect of Injectable Platelet-rich Fibrin (i-PRF) on the Rate of Orthodontic En Masse Retraction of Maxillary Anterior Teeth: A Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The aim of this study is to investigate the effect of local injection of injectable platelet rich fibrin (i-PRF) on the rate of orthodontic en masse retraction of anterior teeth clinically and to report any associated pain as well.
Detailed Description:
Trial will be carried on 2 groups, each involve 13 participants with a total of 26 participants.
1. Subject examination to ensure he/she meets the eligibility criteria of the research.
2. Leveling and alignment using fixed orthodontic appliance.
3. Upper first premolars extraction as a part of the orthodontic treatment planning.
4. With the starting of en masse retraction, injection of the (i-prf) obtained from venous sample palatally and distally to the anterior teeth in the intervention group, and sham injection in the control group. The injection in both groups will be done just before retraction, 21 and 42 days after beginning of retraction Rate of en masse retraction will be calculated for patients in both groups at the monthly basis for for months after starting en masse retraction, data will be analyzed statistically.
1. Subject examination to ensure he/she meets the eligibility criteria of the research.
2. Leveling and alignment using fixed orthodontic appliance.
3. Upper first premolars extraction as a part of the orthodontic treatment planning.
4. With the starting of en masse retraction, injection of the (i-prf) obtained from venous sample palatally and distally to the anterior teeth in the intervention group, and sham injection in the control group. The injection in both groups will be done just before retraction, 21 and 42 days after beginning of retraction Rate of en masse retraction will be calculated for patients in both groups at the monthly basis for for months after starting en masse retraction, data will be analyzed statistically.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: