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

NCT ID: NCT06834802

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Grafting with PRF

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.

Group Type ACTIVE_COMPARATOR

PRF

Intervention Type PROCEDURE

PRF membrane will be used for soft tissue grafting around implant

Grafting using Human amniotic membrane (HAM)

immediate implant placement will be done and The HAM plug will be placed into the soft tissue.

Group Type ACTIVE_COMPARATOR

Human amniotic membrane

Intervention Type PROCEDURE

Human amniotic membrane will be used for soft tissue grafting around implan

No Grafting

Immediate implant placement will be done and with no soft tissue grafting

Group Type ACTIVE_COMPARATOR

No grafting

Intervention Type PROCEDURE

No soft tissue grafting around implant

Interventions

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PRF

PRF membrane will be used for soft tissue grafting around implant

Intervention Type PROCEDURE

Human amniotic membrane

Human amniotic membrane will be used for soft tissue grafting around implan

Intervention Type PROCEDURE

No grafting

No soft tissue grafting around implant

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients at least 18 years old, with non-restorable first and second molars.
2. Minimum remaining alveolar height of four to six millimeters distance from the apex of the socket to the floor of maxillary sinus for maxillary teeth and minimum remaining alveolar height of six millimeters distance from the apex of the socket to the inferior alveolar nerve for mandibular teeth.
3. Minimum alveolar Bucco-palatal dimension of 7 mm.

Exclusion Criteria

1. Patients with known systemic diseases which can affect normal bone formation or blood coagulation.
2. Patients who are smokers.
3. Presence of signs of active infection or pus formation.
4. Absence or loss of buccal wall prior to implant placement.
5. Bad oral hygiene
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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faculty of oral and dental medicine , Suez university

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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3D soft tissue assessment

Identifier Type: -

Identifier Source: org_study_id

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