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NCT Number: NCT06834802

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of oral and dental medicine , Suez university

Cairo, Cairo Governorate, 123456, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

PRF

Procedure

PRF membrane will be used for soft tissue grafting around implant

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

Primary outcomes

  1. Soft tissue healing

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

    Surface area/intraoral scanner

Secondary outcomes

  1. post operative pain

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

    Visual analog scale: numerical scale in which 0 is no pain and 10 is maximum pain

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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