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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grafting with PRF | Active Comparator | immediate implant will be placed and PRF membrane will be placed into the soft tissue. The PRF plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. |
|
| Grafting using Human amniotic membrane (HAM) | Active Comparator | immediate implant placement will be done and The HAM plug will be placed into the soft tissue. |
|
| No Grafting | Active Comparator | Immediate implant placement will be done and with no soft tissue grafting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRF | Procedure | PRF membrane will be used for soft tissue grafting around implant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Soft tissue healing | Surface area/intraoral scanner | Baseline, every day for the first week, day after day second week, once in third and fourth week |
| Measure | Description | Time Frame |
|---|---|---|
| post operative pain | Visual analog scale: numerical scale in which 0 is no pain and 10 is maximum pain | Baseline, every day for the first week, day after day second week, once in third and fourth week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of oral and dental medicine , Suez university | Cairo | Cairo Governorate | 123456 | Egypt |
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Blinding of outcome assessors and participants will be achieved as the different outcomes will be assessed for all groups by assessors other than the researchers doing the procedures.
| Human amniotic membrane |
| Procedure |
Human amniotic membrane will be used for soft tissue grafting around implan |
|
| No grafting | Procedure | No soft tissue grafting around implant |
|