Clinical trial NCT06875830: Comparison of Immediate Implant Placement With Titanium Mesh Versus Collagen Membrane in Type II Socket: A Randomized Clinical Trial
Official title: Comparison of Flapless Immediate Implant Placement With Titanium Mesh Versus Immediate Implants Placement With Collagen Membrane in Type II Socket: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bone Augmentation
Badly Broken Maxillary Premolars Indicated for Extraction
Lead sponsor: Misr International University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Buccal bone thickness
timeFrame: at baseline, 6 and 12 months
Secondary outcomes:
measure: Soft tissue thickness
timeFrame: at baseline 6 and 12 months
measure: Keratinized tissue width
timeFrame: at baseline, 6 and 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of oral & dental Medicine,Misr international University
Study officials:
affiliation: Assistant lecturer
name: ahmed H Farid, Masters
role: PRINCIPAL_INVESTIGATOR
References: