Immediate ImplantNCT07337837
Immediate Implant Placement in Type ii Socket by Vestibular Socket Therapy Using Collagen Membrane
A study testing vestibular socket therapy and open flap surgery in people with Immediate Implant and Vestibular Socket Therapy, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: Immediate implant placement has become a routine and regular clinical practice. When the labial bone plate develops a dehiscence-type defect, delayed implant placement was recommended to give suitable amount of time for soft tissue thickening. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Immediate Implant, Vestibular Socket Therapy, Type II Socket
- What is being tested?
- vestibular socket therapy and open flap surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 15 Jun 2025
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both sexes with a single maxillary tooth (second bicuspid to second bicuspid) indicate for extraction due to fracture, badly decayed or endodontic lesionswith expected labial bone defect
Who cannot join
- Pregnancy.
- Patients with any systematic disease that could complicate the surgical phase or affect osseointegration as osteoporosis and uncontrolled diabetes mellitus.
- Periodontal disease or gingival recession.
- Heavy smokers (more than 30 cigarette / day).
- Patients with poor oral hygiene
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria
About this study
Official title: Immediate Implant Placement in Type ii Socket by Vestibular Socket Therapy Using Collagen Membrane (Randomized Controlled Clinical Trial)
Background: Immediate implant placement has become a routine and regular clinical practice. When the labial bone plate develops a dehiscence-type defect, delayed implant placement was recommended to give suitable amount of time for soft tissue thickening. However, it has a number of drawbacks, including a lengthy treatment period, the requirement for two surgical procedures, and a potential loss of facial contour. When immediate implant is placed with flap elevation and guided bone regeneration in type II socket, labial bone augmentation results were satisfactory, but in terms of soft tissue, it led to midfacial recession and loss of soft tissue contour, resulting in a compromised final esthetic result. To reduce these drawbacks, implant can be immediately placed by vestibular socket therapy using collagen membrane.
Aim of this study: To compare labial bone augmentation in immediate implant placement in type II extraction sockets by using collagen membrane placed by two different modalities.
- Conditions
- Immediate Implant, Vestibular Socket Therapy, Type II Socket
- Being tested
- vestibular socket therapy, open flap surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular socket therapyProcedure or surgery
patients will undergo immediate implant placement and a mucoperiosteal tunnel will be made through a vestibular incision till labial orifice of the socket, a collagen membrane will be inserted under the tunnel and stabilized by membrane tacks. The space between the membrane and implant will be filled with mixture of allograft and xenograft bone material and any autogenous bone chips harvested from local surgical sites.
open flap surgeryProcedure or surgery
patients will undergo immediate implant placement combined with open flap surgery and labial plate augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Procedure: vestibular socket therapy |
| Control Group | Active comparator | Not described Receives: Procedure: open flap surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in buccal bone thickness
CBCT will be taken for each patient and Labial bone thickness means the distance between the implant surface and the outer surface of bone
Measured: baseline, 3 months, and 6 months
change in buccal bone height
Labial bone height means the distance between the apical end of the implant (which is projected on the baseline image) and the crest of the labial bone of both images
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (3)
Volumetric change of buccal soft tissue contour
The impressions will be taken using lab scanner to create digital surface models in Standard Triangle Language (STL) format, all STL files will be imported to a digital software. The best-fit algorithm will be used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow-up period.
Measured: Baseline and 6 months
change in gingival esthetics
The score incorporates seven domains: mesial papilla, distal papilla, soft tissue level, soft tissue contour, deficient alveolar process, soft tissue color, and texture. Each variable is scored from 0 to 2, with 2 being the best outcome. The total pink esthetic score will be calculated by adding the scores of the seven domains and ranged from 0 to 14 (best overall esthetic outcome).
Measured: Baseline and 6 months
chang in Modified Sulcus Bleeding Index
a score of 0-3 will be assigned to each labial and palatal surface of the implant then the average for each implant will be calculated according to the following criteria: Score 0: No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant.
Score 1: Isolated bleeding spots visible. Score 2: Blood forms a confluent red line on margin. Score 3: Heavy or profuse bleeding
Measured: Baseline and 6 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 2026
- Study start1 Jan 2024
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immediate ImplantStudies 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337837
- Sponsor's protocol ID
- 0809-12/2023
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ebrahim MM, Shabaan AM, Gaweesh YY, ElMekkawy EA, Sakr AA. Immediate implant placement in Type II socket using vestibular socket therapy with pericardial membrane versus simultaneous guided bone regeneration (randomized controlled clinical trial). BMC Oral Health. 2026 May 26;26(1):1001. doi: 10.1186/s12903-026-08626-7.
PubMed 42185891
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement in Type ii Socket by Vestibular Socket Therapy Using Collagen Membrane (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07337837
- Acronym / sponsor ID
- 0809-12/2023
- Conditions
- Immediate Implant, Vestibular Socket Therapy, Type II Socket
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 13 Jan 2026 (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.
Background: Immediate implant placement has become a routine and regular clinical practice. When the labial bone plate develops a dehiscence-type defect, delayed implant placement was recommended to give suitable amount of time for soft tissue thickening. However, it has a number of drawbacks, including a lengthy treatment period, the requirement for two surgical procedures, and a potential loss of facial contour. When immediate implant is placed with flap elevation and guided bone regeneration in type II socket, labial bone augmentation results were satisfactory, but in terms of soft tissue, it led to midfacial recession and loss of soft tissue contour, resulting in a compromised final esthetic result. To reduce these drawbacks, implant can be immediately placed by vestibular socket therapy using collagen membrane.
Aim of this study: To compare labial bone augmentation in immediate implant placement in type II extraction sockets by using collagen membrane placed by two different modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: vestibular socket therapy |
| Control Group | Active comparator | Procedure: open flap surgery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients of both sexes with a single maxillary tooth (second bicuspid to second bicuspid) indicate for extraction due to fracture, badly decayed or endodontic lesionswith expected labial bone defect
Key exclusion criteria (5 listed)
- Pregnancy.
- Patients with any systematic disease that could complicate the surgical phase or affect osseointegration as osteoporosis and uncontrolled diabetes mellitus.
- Periodontal disease or gingival recession.
- Heavy smokers (more than 30 cigarette / day).
- Patients with poor oral hygiene
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 |
|---|---|---|
| vestibular socket therapypatients will undergo immediate implant placement and a mucoperiosteal tunnel will be made through a vestibular incision till labial orifice of the socket, a collagen membrane will be inserted under the tunnel and stabilized by membrane tacks. The space between the membrane and implant will be filled with mixture of allograft and xenograft bone material and any autogenous bone chips harvested from local surgical sites. | Procedure or surgery | Study group |
| open flap surgerypatients will undergo immediate implant placement combined with open flap surgery and labial plate augmentation. | Procedure or surgery | Control Group |
Primary outcome
change in buccal bone thickness
Time frame: baseline, 3 months, and 6 months
CBCT will be taken for each patient and Labial bone thickness means the distance between the implant surface and the outer surface of bone
change in buccal bone height
Time frame: Baseline, 3 months, and 6 months
Labial bone height means the distance between the apical end of the implant (which is projected on the baseline image) and the crest of the labial bone of both images
3 secondary outcomes
Volumetric change of buccal soft tissue contour
Time frame: Baseline and 6 months
change in gingival esthetics
Time frame: Baseline and 6 months
chang in Modified Sulcus Bleeding Index
Time frame: Baseline and 6 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 13 Jan 2026.
- Derived from this study: PubMed 42185891Ebrahim MM, Shabaan AM, Gaweesh YY, ElMekkawy EA, Sakr AA. Immediate implant placement in Type II socket using vestibular socket therapy with pericardial membrane versus simultaneous guided bone regeneration (randomized controlled clinical trial). BMC Oral Health. 2026 May 26;26(1):1001. doi: 10.1186/s12903-026-08626-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vestibular socket therapy and open flap surgery in people with Immediate Implant and Vestibular Socket Therapy, run by Alexandria 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 1 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 13 Jan 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?
change in buccal bone thickness (time frame: baseline, 3 months, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07337837, which also lists 1 linked publication.
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 13 Jan 2026.