Bone AugmentationNCT06875830
Comparison of Immediate Implant Placement With Titanium Mesh Versus Collagen Membrane in Type II Socket:
A study testing collagen membrane and titanium mesh in people with Bone Augmentation and Badly Broken Maxillary Premolars Indicated for Extraction, run by Misr International University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Augmentation, Badly Broken Maxillary Premolars Indicated for Extraction
- What is being tested?
- collagen membrane and titanium mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Mar 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who have at least one remaining root or badly decayed tooth in anterior maxilla.
- Systemically free patients (American Society of Anesthesiologists I; ASA I)
- Patients aged from 21 to 50 years old
- Buccal bone partial deficiency (extraction socket type II)
- Good oral hygiene
- Accepts the follow-up period (cooperative patients)
- Patient accepts to provides an informed consent
Who cannot join
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits such as bruxism
- Smokers
- Pregnant and lactating females
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed H Farid, Masters contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of oral & dental Medicine,Misr international University
Cairo, Heliopolis - Cairo, 123456
Zeinab H AbdelRahman, lecturer, 01221334637, zeinab.hafez@miuegypt.edu.eg
Ahmed H Farid, lecturer, ahmed.fareed@miuegypt.edu.eg
About this study
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
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.
Read the 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.
- Being tested
- collagen membrane, titanium mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagen membraneProcedure or surgery
augmentation of the buccal plate of bone with xenograft and collagen membrane
titanium meshProcedure or surgery
augmentation of the buccal plate of bone with xenograft and titanium mesh
| Study group | Role | What they receive |
|---|---|---|
| immediate implant with collagen membrane | Active comparator | immediate implant placement will be done and augmentation of the buccal bone will be done with xenograft and collagen membrane Receives: Procedure: collagen membrane |
| immediate implant with titanium mesh | Active comparator | immediate implant placement will be done and augmentation of the buccal bone will be done with xenograft and titanium mesh Receives: Procedure: titanium mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal bone thickness
assessment of the Buccal bone thickness in mm using CBCT
Measured: at baseline, 6 and 12 months
Secondary outcomes (2)
Soft tissue thickness
Soft tissue thickness will be assessed in mm using volumetric analysis method
Measured: at baseline 6 and 12 months
Keratinized tissue width
measurement of the keratinized tissue width in mm using periodontal probe
Measured: at baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start6 Mar 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ahmed H Farid, Masters, Principal investigator, Assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875830
- Sponsor's protocol ID
- PER5253015
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06875830
- Acronym / sponsor ID
- PER5253015
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate implant with collagen membrane | Active comparator | Procedure: collagen membraneimmediate implant placement will be done and augmentation of the buccal bone will be done with xenograft and collagen membrane |
| immediate implant with titanium mesh | Active comparator | Procedure: titanium meshimmediate implant placement will be done and augmentation of the buccal bone will be done with xenograft and titanium mesh |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients who have at least one remaining root or badly decayed tooth in anterior maxilla.
- Systemically free patients (American Society of Anesthesiologists I; ASA I)
- Patients aged from 21 to 50 years old
- Buccal bone partial deficiency (extraction socket type II)
- Good oral hygiene
Key exclusion criteria (3 listed)
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits such as bruxism
- Smokers
- Pregnant and lactating females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collagen membraneaugmentation of the buccal plate of bone with xenograft and collagen membrane | Procedure or surgery | immediate implant with collagen membrane |
| titanium meshaugmentation of the buccal plate of bone with xenograft and titanium mesh | Procedure or surgery | immediate implant with titanium mesh |
Primary outcome
Buccal bone thickness
Time frame: at baseline, 6 and 12 months
assessment of the Buccal bone thickness in mm using CBCT
2 secondary outcomes
Soft tissue thickness
Time frame: at baseline 6 and 12 months
Keratinized tissue width
Time frame: at baseline, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Bone Augmentation
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingObservational study
Impact of Gingival Phenotype on Guided Bone Regeneration in the Maxillary Anterior Region
Guided Bone Regeneration
RecruitingPhase 1
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed H Farid, Masters contact
ahmed H Farid, Masters principal investigator
Assistant lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collagen membrane and titanium mesh in people with Bone Augmentation and Badly Broken Maxillary Premolars Indicated for Extraction, run by Misr International University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hani El Nahas, PhD (+201221334637, zeinab.hafez@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buccal bone thickness (time frame: at baseline, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.