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

NCT06834802 | Active Not Recruiting DMC

• 1 other identifier: 3D soft tissue assessment
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

jumping gap; immediate implant placemnet; soft tissue around implant; soft tissue healing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• post operative pain

  Baseline, every day for the first week, day after day second week, once in third and fourth week

Study Arms (3)

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.

Procedure: PRF

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.

Procedure: Human amniotic membrane

No Grafting

ACTIVE COMPARATOR

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

Procedure: No grafting

Interventions

PRF PROCEDURE

PRF membrane will be used for soft tissue grafting around implant

Grafting with PRF

Human amniotic membrane PROCEDURE

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

Grafting using Human amniotic membrane (HAM)

No grafting PROCEDURE

No soft tissue grafting around implant

No Grafting

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients at least 18 years old, with non-restorable first and second molars.
• 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.
• Minimum alveolar Bucco-palatal dimension of 7 mm.

You may not qualify if:

• Patients with known systemic diseases which can affect normal bone formation or blood coagulation.
• Patients who are smokers.
• Presence of signs of active infection or pus formation.
• Absence or loss of buccal wall prior to implant placement.
• Bad oral hygiene

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of oral and dental medicine , Suez university

Cairo, Cairo Governorate, 123456, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: January 7, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-01

Locations

EG (1)