Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT06834802
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3D Analysis of Soft Tissue Healing After Immediate Implant Placement Using PRF Vs HAM
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
3D Analysis of Soft Tissue Healing After Immediate Implant Placement in Molar Sites Using PRF Vs HAM: A Randomized Controlled Clinical Study in Molar Sites Using PRF Vs HAM: A Randomized Controlled Clinical Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
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:
None
Brief Summary:
Statement of the problem: Soft tissue healing following immediate implant placement is one of the major factors that affect implant restoration, function \& success.
Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with immediate implant placement in the molar region.
Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with immediate implant placement in the molar region.
Detailed Description:
Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with immediate implant placement in the molar region.
Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in molar sites region requiring implant placement. They will be randomly allocated to three equal groups. Group A (test group, n=12) will receive immediate implants (grafting with PRF), group B (test group, n=12) will receive immediate implants (grafting with HAM) and group c (test group, n=12) will receive immediate implants (no grafting). After implant placement, soft tissue healing (1ry outcome) and postoperative pain (2nd outcome) will be assessed. The parameters will be assessed at baseline, every day for the first week, day after day second week, once in third and fourth week. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.
Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in molar sites region requiring implant placement. They will be randomly allocated to three equal groups. Group A (test group, n=12) will receive immediate implants (grafting with PRF), group B (test group, n=12) will receive immediate implants (grafting with HAM) and group c (test group, n=12) will receive immediate implants (no grafting). After implant placement, soft tissue healing (1ry outcome) and postoperative pain (2nd outcome) will be assessed. The parameters will be assessed at baseline, every day for the first week, day after day second week, once in third and fourth week. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.
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?: