Badly Broken Tooth in a Socket Type II Eligible to be Replaced by Immediate ImplantNCT06324747
Soft Tissue Stability in Immediate Implant Placement Using (VST) Versus Conventional Flap in Type II Extraction Sockets
A study testing Vestibular socket therapy and conventional full thickness flap in people with Badly Broken Tooth in a Socket Type II Eligible to be Replaced by Immediate Implant, run by British University In Egypt at 1 site in Egypt.
Trial summary
This study compare between the vestibular socket therapy (VST) and the traditional mucoperiosteal flap reflection in immediate implant placement in type II extraction socket in the esthetic zone. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Badly Broken Tooth in a Socket Type II Eligible to be Replaced by Immediate Implant
- What is being tested?
- Vestibular socket therapy and conventional full thickness flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Oct 2023to 1 Dec 2024
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hopeless maxillary tooth in the esthetic region missing coronal tooth structure
- Type II socket (deficient labial plate of bone and intact overlying soft tissues)
- Adequate palatal bone, ≥ 3 mm apical bone to engage the immediately placed implants
Who cannot join
- Smokers
- Pregnant women
- Patients with systemic diseases
- History of chemotherapy or radiotherapy within the past 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soft Tissue Stability in Immediate Implant Placement Using the Vestibular Socket Therapy Versus Conventional Flap in Type II Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
This study compare between the vestibular socket therapy (VST) and the traditional mucoperiosteal flap reflection in immediate implant placement in type II extraction socket in the esthetic zone.
The technique of vestibular socket therapy (VST), introduced by Elaskry, enables the placement of implants immediately while simultaneously rehabilitating the entire socket, resulting in excellent esthetic and functional outcomes that meet the expectations of patients. VST involves socket augmentation through a minimally invasive vestibular access incision, eliminating the need for the traditional mucoperiosteal flap reflection, regardless of the extent of socket compromise.
Read the detailed description
Several methods have been suggested for the treatment of class 2 socket types with immediate implant placement. One such technique is the immediate dento-alveolar restoration (IDR), which involves the incorporation of a tuberosity bone graft into the buccal defect, restoring the missing buccal bone walls. However, this technique has some limitations, including the lack of graft stabilization to the host bed, the high rate of bone graft remodeling, and the limited availability of tuberosity bone when wisdom teeth are present.
In contrast, Buser D. extensively researched the early implant placement method. This approach involves extracting the tooth and then waiting for a delay period of 8-12 weeks. According to the authors, this timeframe allows for the development of ample keratinized tissues, the elimination of socket infection, and the occurrence of post-extraction bone remodeling.
In contrast, both early placement and contour augmentation procedures have demonstrated certain drawbacks. These include the collapse of socket walls in both horizontal and vertical directions after tooth extraction, the need for a lengthy treatment duration that can extend up to 8 months, the challenges of maintaining provisional restorations during this extended period, and the potential for post-restorative socket tissue recession due to the reflection of the mucoperiosteal flap . As a result, achieving a successful esthetic treatment outcome becomes difficult to predict.
The technique of vestibular socket therapy (VST), introduced by Elaskry et al. , enables the placement of implants immediately while simultaneously rehabilitating the entire socket, resulting in excellent esthetic and functional outcomes that meet the expectations of patients. VST involves socket augmentation through a minimally invasive vestibular access incision, eliminating the need for the traditional mucoperiosteal flap reflection, regardless of the extent of socket compromise .
The procedure involves making a horizontal incision in the vestibule at the base of the mucogingival junction of the extracted tooth. This is followed by implant placement without the need for a flap, grafting the compromised socket walls through the vestibular access incision. The labial bone defect, which has been grafted with a bone graft, is then protected using a cortical equine membrane, and finally, the socket opening is sealed with a customized healing collar.
- Being tested
- Vestibular socket therapy, conventional full thickness flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular socket therapyProcedure or surgery
Also called VST
Vestibular socket therapy will be used for the intervention.
conventional full thickness flapProcedure or surgery
reflecting the mucoperiosteum to access the extraction socket
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Control group will have a full thickness flap, followed by an immediate implant placement using a surgical guide. Then a guided bone regeneration will be achieved by bone graft (autogenous bone chips and xenograft particles and a membrane barrier 1 mm thickness will be applied. The membrane shield then will be stabilized to the apical bone using 2 membrane tacks, customized healing abutment will be connected , then, the elevated flap will be sutured to its original position. Receives: Procedure: conventional full thickness flap |
| Test group | Active comparator | Elaskary Vestibular socket therapy instruments will be used for the intervention, A 1 cm long vestibular access incision at the allocated hopeless tooth will be made at the base of the hopeless tooth to the adjacent teeth. The vestibular pouch will then be dissected in an incisal direction exposing the total socket area and allowing direct access to the socket environment. An immediate implant will be installed using a surgical guide. A membrane shield 1 mm thick will be, trimmed, and tucked through the vestibular access incision starting at 1 mm beyond the socket orifice and reaching to the apical area of the socket. The gap and/ or the defect between the implant body and the shield will then be filled with the same grafting components so the control group. Finally, the vestibular incision will be secured with sutures. The socket will be sealed with a customized healing abutment. Receives: Procedure: Vestibular socket therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft Tissue Stability
it will be measured digitally using the intraoral scanner. A preoperative scanning, immediate postoperative, 2 months postoperative and 8 months postoperative scanning will be done.
Tool to be used: 3shape trios 4
what will be assessed:
- gingival recession
- loss of interdental papillae height
Data will be measured in millimeters
Measured: 8 months
Secondary outcomes (1)
Bone Regeneration
measuring the thickness of the labial plate of bone.
It will be measured preoperatively, immediate postoperative to measure the amount of the augmented bone, 2 months postoperatively and 8 months post operative.
Tool to be used: cone beam computed tomography (cbct)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start23 Oct 2023
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Badly Broken Tooth in a Socket Type II Eligible to be Replaced by 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
- Model description
- Two equal parallel groups with a 1:1 allocation ratio to receive either vestibular socket therapy (test group) or to be treated with conventional mucoperiosteal flap (control group).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed shawky, British University In Egypt
- Investigators
- Mohamed Shawky, BDS, Principal investigator, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324747
- Sponsor's protocol ID
- 23-046
- Status last verified
- Aug 2025
- First submitted
- 4 Dec 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Stability in Immediate Implant Placement Using the Vestibular Socket Therapy Versus Conventional Flap in Type II Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06324747
- Acronym / sponsor ID
- 23-046
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 22 Mar 2024 (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.
This study compare between the vestibular socket therapy (VST) and the traditional mucoperiosteal flap reflection in immediate implant placement in type II extraction socket in the esthetic zone.
The technique of vestibular socket therapy (VST), introduced by Elaskry, enables the placement of implants immediately while simultaneously rehabilitating the entire socket, resulting in excellent esthetic and functional outcomes that meet the expectations of patients. VST involves socket augmentation through a minimally invasive vestibular access incision, eliminating the need for the traditional mucoperiosteal flap reflection, regardless of the extent of socket compromise.
Detailed description
Several methods have been suggested for the treatment of class 2 socket types with immediate implant placement. One such technique is the immediate dento-alveolar restoration (IDR), which involves the incorporation of a tuberosity bone graft into the buccal defect, restoring the missing buccal bone walls. However, this technique has some limitations, including the lack of graft stabilization to the host bed, the high rate of bone graft remodeling, and the limited availability of tuberosity bone when wisdom teeth are present.
In contrast, Buser D. extensively researched the early implant placement method. This approach involves extracting the tooth and then waiting for a delay period of 8-12 weeks. According to the authors, this timeframe allows for the development of ample keratinized tissues, the elimination of socket infection, and the occurrence of post-extraction bone remodeling.
In contrast, both early placement and contour augmentation procedures have demonstrated certain drawbacks. These include the collapse of socket walls in both horizontal and vertical directions after tooth extraction, the need for a lengthy treatment duration that can extend up to 8 months, the challenges of maintaining provisional restorations during this extended period, and the potential for post-restorative socket tissue recession due to the reflection of the mucoperiosteal flap . As a result, achieving a successful esthetic treatment outcome becomes difficult to predict.
The technique of vestibular socket therapy (VST), introduced by Elaskry et al. , enables the placement of implants immediately while simultaneously rehabilitating the entire socket, resulting in excellent esthetic and functional outcomes that meet the expectations of patients. VST involves socket augmentation through a minimally invasive vestibular access incision, eliminating the need for the traditional mucoperiosteal flap reflection, regardless of the extent of socket compromise .
The procedure involves making a horizontal incision in the vestibule at the base of the mucogingival junction of the extracted tooth. This is followed by implant placement without the need for a flap, grafting the compromised socket walls through the vestibular access incision. The labial bone defect, which has been grafted with a bone graft, is then protected using a cortical equine membrane, and finally, the socket opening is sealed with a customized healing collar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two equal parallel groups with a 1:1 allocation ratio to receive either vestibular socket therapy (test group) or to be treated with conventional mucoperiosteal flap (control group).
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Procedure: conventional full thickness flapControl group will have a full thickness flap, followed by an immediate implant placement using a surgical guide. Then a guided bone regeneration will be achieved by bone graft (autogenous bone chips and xenograft particles and a membrane barrier 1 mm thickness will be applied. The membrane shield then will be stabilized to the apical bone using 2 membrane tacks, customized healing abutment will be connected , then, the elevated flap will be sutured to its original position. |
| Test group | Active comparator | Procedure: Vestibular socket therapyElaskary Vestibular socket therapy instruments will be used for the intervention, A 1 cm long vestibular access incision at the allocated hopeless tooth will be made at the base of the hopeless tooth to the adjacent teeth. The vestibular pouch will then be dissected in an incisal direction exposing the total socket area and allowing direct access to the socket environment. An immediate implant will be installed using a surgical guide. A membrane shield 1 mm thick will be, trimmed, and tucked through the vestibular access incision starting at 1 mm beyond the socket orifice and reaching to the apical area of the socket. The gap and/ or the defect between the implant body and the shield will then be filled with the same grafting components so the control group. Finally, the vestibular incision will be secured with sutures. The socket will be sealed with a customized healing abutment. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Hopeless maxillary tooth in the esthetic region missing coronal tooth structure
- Type II socket (deficient labial plate of bone and intact overlying soft tissues)
- Adequate palatal bone, ≥ 3 mm apical bone to engage the immediately placed implants
Key exclusion criteria (4 listed)
- Smokers
- Pregnant women
- Patients with systemic diseases
- History of chemotherapy or radiotherapy within the past 2 years.
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 therapyAlso: VSTVestibular socket therapy will be used for the intervention. | Procedure or surgery | Test group |
| conventional full thickness flapreflecting the mucoperiosteum to access the extraction socket | Procedure or surgery | Control group |
Primary outcome
Soft Tissue Stability
Time frame: 8 months
it will be measured digitally using the intraoral scanner. A preoperative scanning, immediate postoperative, 2 months postoperative and 8 months postoperative scanning will be done. Tool to be used: 3shape trios 4 what will be assessed: * gingival recession * loss of interdental papillae height Data will be measured in millimeters
1 secondary outcome
Bone Regeneration
Time frame: 8 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 22 Aug 2025.
- Individual participant dataSharing planned: Yes
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.
Mohamed Shawky, BDS principal investigator
British University In Egypt
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 conventional full thickness flap in people with Badly Broken Tooth in a Socket Type II Eligible to be Replaced by Immediate Implant, run by British University In Egypt 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 3 inclusion and 4 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 22 Aug 2025. 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?
Soft Tissue Stability (time frame: 8 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 22 Aug 2025.