Clinical trial NCT06834802: 3D Analysis of Soft Tissue Healing After Immediate Implant Placement Using PRF Vs HAM
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Soft tissue healing
timeFrame: Baseline, every day for the first week, day after day second week, once in third and fourth week
Secondary outcomes:
measure: post operative pain
timeFrame: Baseline, every day for the first week, day after day second week, once in third and fourth week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of oral and dental medicine , Suez university
Study officials:
References: