NCT06834802

3D Analysis of Soft Tissue Healing After Immediate Implant Placement Using PRF Vs HAM

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Badly Broken Maxillary Premolars Indicated for Extraction
• Badly Broken Down Vital Teeth

Interventions

Type	Name	Description
PROCEDURE	PRF	PRF membrane will be used for soft tissue grafting around implant
PROCEDURE	Human amniotic membrane	Human amniotic membrane will be used for soft tissue grafting around implan
PROCEDURE	No grafting	No soft tissue grafting around implant

Timeline

• Start date: 2025-01-07
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2025-02-19
• Last updated: 2025-02-19

Locations

1 site across 1 country: Egypt