Comparison of Immediate Implant Placement With Titanium Mesh Versus Collagen Membrane in Type II Socket: A Randomized Clinical Trial

Not Applicable

Active, not recruiting

• Conditions: Bone Augmentation; Badly Broken Maxillary Premolars Indicated for Extraction

• Registration Number: NCT06875830
• Lead Sponsor: Misr International University

Brief Summary

Statement of the problem: Immediate implant placement is faced with several problems. One of the most important issues is dealing with defects in the buccal plate of bone in the esthetic zone.

Aim: The aim of this study is to assess the buccal bone thickness after augmentation with titanium mesh and xenograft upon flapless immediate implant placement.

Detailed Description

Statement of the problem: Immediate implant placement is faced with several problems. One of the most important issues is dealing with defects in the buccal plate of bone in the esthetic zone.

Aim: The aim of this study is to assess the buccal bone thickness after augmentation with titanium mesh and xenograft upon flapless immediate implant placement.

Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in the anterior region and buccal bone deficiency requiring implant placement. They will be randomly allocated to two equal groups. Group A (test group, n=10) will receive immediate implants (grafting with xenograft covered by titanium mesh covered by collagen membrane), while group B (test group, n=10) will receive immediate implants (grafting with xenograft covered by collagen membrane). The parameters ( buccal bone thickness \& soft tissue thickness will be assessed at 6 \& 12 months. 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 Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-06
• Study First Submitted: 2025-03-09
• Study First Submitted QC: 2025-03-09
• Last Update Submitted: 2025-03-09
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-07-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients who have at least one remaining root or badly decayed tooth in anterior maxilla.
2. Systemically free patients (American Society of Anesthesiologists I; ASA I)
3. Patients aged from 21 to 50 years old
4. Buccal bone partial deficiency (extraction socket type II)
5. Good oral hygiene
6. Accepts the follow-up period (cooperative patients)
7. Patient accepts to provides an informed consent

Exclusion Criteria

1. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits such as bruxism
2. Smokers
3. Pregnant and lactating females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Buccal bone thickness	at baseline, 6 and 12 months	assessment of the Buccal bone thickness in mm using CBCT

Secondary Outcome Measures

Name	Time	Method
Soft tissue thickness	at baseline 6 and 12 months	Soft tissue thickness will be assessed in mm using volumetric analysis method
Keratinized tissue width	at baseline, 6 and 12 months	measurement of the keratinized tissue width in mm using periodontal probe

Trial Locations

Locations (1)

Faculty of oral & dental Medicine,Misr international University; 🇪🇬 Cairo, Egypt