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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Augmentation; Badly Broken Maxillary Premolars Indicated for Extraction
• Intervention / Treatment: Procedure: collagen membrane; Procedure: titanium mesh

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 123456
    • Faculty of oral & dental Medicine,Misr international University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: immediate implant with collagen membrane; immediate implant placement will be done and augmentation of the buccal bone will be done with xenograft and collagen membrane	Procedure: collagen membrane; augmentation of the buccal plate of bone with xenograft and collagen membrane
Active Comparator: immediate implant with titanium mesh; immediate implant placement will be done and augmentation of the buccal bone will be done with xenograft and titanium mesh	Procedure: titanium mesh; augmentation of the buccal plate of bone with xenograft and titanium mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Buccal bone thickness	assessment of the Buccal bone thickness in mm using CBCT	at baseline, 6 and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Misr International University
• Investigators: Principal Investigator: ahmed H Farid, Masters, Assistant Lecturer

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 9, 2025
• First Submitted That Met QC Criteria: March 9, 2025
• First Posted (Actual): March 13, 2025

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PER5253015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No