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

N/AActive Not RecruitingNCT06834802

Ain Shams University36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

PRFPROCEDURE

PRF membrane will be used for soft tissue grafting around implant

Human amniotic membranePROCEDURE

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

No graftingPROCEDURE

No soft tissue grafting around implant

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

faculty of oral and dental medicine , Suez university

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

Soft tissue healing

Surface area/intraoral scanner

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

Secondary Outcomes

post operative pain

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.