Immediate Dental Implant PlacementNCT04224935
Comparing the Position of Collagen Membrane During Immediate Implant Placement
A study testing Collagen membrane inside and Collagen membrane outside in people with Immediate Dental Implant Placement and Immediate Implant Placement, run by Ain Shams University at 1 site in Egypt.
Trial summary
evaluation of the use of collagen membrane inside the socket and outside it during immediate implant placement Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implant Placement, Immediate Implant Placement, Badly Decayed Teeth
- What is being tested?
- Collagen membrane inside and Collagen membrane outside
- 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
- 1 Dec 2018to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically free patients (American Society of Anesthesiologists I; ASA I).
- Age range (20 -50) years.
- Good compliance with the plaque control instructions following initial therapy.
- Patients diagnosed badly decayed tooth in esthetic zone indicated for immediate implant placement
- Availability for follow up and maintenance program.
Who cannot join
- Patient suffering from periodontitis
- Presence of smoking habit.
- Presence of occlusion interference.
- Pregnant and lactating females.
- Vulnerable group of patients (handicapped, mentally retarded and prisoners).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compraing the Effect of Placement of Collagen Membrane Inside the Extraction Socket and Outside it During Immediate Implant Placement
evaluation of the use of collagen membrane inside the socket and outside it during immediate implant placement
Read the detailed description
Twenty patients, who are candidates for immediate implant placement, will participate in this prospective clinical trial.
Group 1(10 patients) :
immediate implant placement with bone graft and collagen memebrane outside the buccal plate
Group 2 (Control group)(10 patients) :
immediate implant placement with bone graft and collagen memebrane inside the buccal plate assessment of the buccal bone thickness assessment of soft tissue thickness
- Esthetic outcome evaluation Will be done using the root coverage esthetic score (Cairo et al. 2009) that include
Both evaluations will be done at 3, 6 and 9 months
- Being tested
- Collagen membrane inside, Collagen membrane outside
- Keywords
- immediate implant placement, badly decayed tooth in esthetic zone, collagen membrane, xenograft, temporization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen membrane insideProcedure or surgery
during immediate implant placement the collagen membrane will be placed in the jumping gap
Collagen membrane outsideProcedure or surgery
during immediate implant placement the collagen membarne will be placed on the surface of the buccal plate of bone
| Study group | Role | What they receive |
|---|---|---|
| collagen membrane inside | Active comparator | during immediate implant placement collagen membrane will be placed into the jumping gap Receives: Procedure: Collagen membrane inside |
| collagen membrane outside | Active comparator | during immedoate implant placement collagen membrane will be placed on the outersurface of the buccal plate of bone Receives: Procedure: Collagen membrane outside |
What is being measured
The primary outcome is the main question the study is designed to answer.
buccal plate of bone thickness
assessment of the buccal plate of bone will be determined in mm from CBCT
Measured: baseline 12 months
Secondary outcomes (1)
soft tissue thickness (Volumetric assessment)
Preoperative scanning will be done. At 6,12 months after surgical procedure the same procedure will be done to determine the soft tissue thickness after the surgery. The difference between the tissue thickness before and after
Measured: 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 Jan 2020
- Study start1 Dec 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Dental Implant PlacementStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab hafez, Misr International University
- Investigators
- Mai Shafik, professor, Study chair, Misr international univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224935
- Sponsor's protocol ID
- 453
- Status last verified
- Feb 2026
- First submitted
- 1 Jan 2020
- Last updated
- 18 Feb 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compraing the Effect of Placement of Collagen Membrane Inside the Extraction Socket and Outside it During Immediate Implant Placement
- ClinicalTrials.gov ID
- NCT04224935
- Acronym / sponsor ID
- 453
- Keywords
- immediate implant placement, badly decayed tooth in esthetic zone, collagen membrane, xenograft, temporization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 13 Jan 2020 (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.
evaluation of the use of collagen membrane inside the socket and outside it during immediate implant placement
Detailed description
Twenty patients, who are candidates for immediate implant placement, will participate in this prospective clinical trial.
Group 1(10 patients) :
immediate implant placement with bone graft and collagen memebrane outside the buccal plate
Group 2 (Control group)(10 patients) :
immediate implant placement with bone graft and collagen memebrane inside the buccal plate assessment of the buccal bone thickness assessment of soft tissue thickness
- Esthetic outcome evaluation Will be done using the root coverage esthetic score (Cairo et al. 2009) that include
Both evaluations will be done at 3, 6 and 9 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| collagen membrane inside | Active comparator | Procedure: Collagen membrane insideduring immediate implant placement collagen membrane will be placed into the jumping gap |
| collagen membrane outside | Active comparator | Procedure: Collagen membrane outsideduring immedoate implant placement collagen membrane will be placed on the outersurface of the buccal plate of bone |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Systemically free patients (American Society of Anesthesiologists I; ASA I).
- Age range (20 -50) years.
- Good compliance with the plaque control instructions following initial therapy.
- Patients diagnosed badly decayed tooth in esthetic zone indicated for immediate implant placement
- Availability for follow up and maintenance program.
Key exclusion criteria (5 listed)
- Patient suffering from periodontitis
- Presence of smoking habit.
- Presence of occlusion interference.
- Pregnant and lactating females.
- Vulnerable group of patients (handicapped, mentally retarded and prisoners).
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 membrane insideduring immediate implant placement the collagen membrane will be placed in the jumping gap | Procedure or surgery | collagen membrane inside |
| Collagen membrane outsideduring immediate implant placement the collagen membarne will be placed on the surface of the buccal plate of bone | Procedure or surgery | collagen membrane outside |
Primary outcome
buccal plate of bone thickness
Time frame: baseline 12 months
assessment of the buccal plate of bone will be determined in mm from CBCT
1 secondary outcome
soft tissue thickness (Volumetric assessment)
Time frame: baseline, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Immediate Dental Implant Placement
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
RecruitingPhase 2/3
Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
Dental Implant, Wound Healing
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Recruiting
Melatonin Effect on Immediate Dental Implants in the Posterior Mandible
Dental Implant, Immediate Dental Implant Placement
Not yet recruiting
Do Immediate Digital Workflows Increase Patient Value?
Dental Implant, Implant Therapy
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. This study is not recruiting at the moment.
Mai Shafik, professor study chair
Misr international univeristy
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 inside and Collagen membrane outside in people with Immediate Dental Implant Placement and Immediate Implant Placement, run by Ain Shams 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 18 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
buccal plate of bone thickness (time frame: baseline 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 18 Feb 2026.