Dental Implant in Compromised Adjacent SocketsNCT06673446
Soft Tissue Stability in the Esthetic Zone: A Randomized Clinical Trial Comparing Vestibular Socket Therapy With Contour Augmentation for Compromised Adjacent Sockets
A study testing vestibular socket therapy in people with Dental Implant in Compromised Adjacent Sockets, run by British University In Egypt at 1 site in Egypt.
Trial summary
While early implant placement with guided bone regeneration (GBR) offers advantages, the desire for reduced treatment time and fewer surgical steps continues to drive the exploration of alternative approaches. In this context, the recent introduction of vestibular socket therapy (VST) presents an intriguing option. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant in Compromised Adjacent Sockets
- What is being tested?
- vestibular socket therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2025to Jan 2026
- 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
- Adults (20 to 50)
- patients with two adjacent hopeless maxillary teeth or remaining roots 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, thereby achieving optimum primary stability (a minimum of 30 Ncm insertion torque) following teeth extraction.
- acceptable compliance and oral hygiene.
Who cannot join
- medically compromised patients. (Systemic diseases).
- general contraindication for implant placement. (Untreated periodontitis, severe bruxism , immunosuppression , uncontrolled diabetes , smokers , patients under radiation therapy, patients on bisphosphonate medications).
Trial locations and contacts
1 site in 1 country.
About this study
While early implant placement with guided bone regeneration (GBR) offers advantages, the desire for reduced treatment time and fewer surgical steps continues to drive the exploration of alternative approaches. In this context, the recent introduction of vestibular socket therapy (VST) presents an intriguing option. VST utilizes a minimally invasive tunnel access technique through the vestibular area to perform socket augmentation for immediate implant placement in compromised extraction sockets .
Read the detailed description
The concept of immediate implant placement has been around for a while. Professor Wilfried Schulte conducted the first study on this technique in 1978, Extensive studies conducted over the past 40 years have demonstrated that immediate implant placement is a safe and effective method for restoring teeth that are badly destructed.
While immediate implant placement has been shown as a viable option, new studies using advanced imaging techniques (cone beam CT scans) reveal limitations in the front upper jaw (anterior maxilla).
- Thin Bone Walls: These scans show that a thick bone wall, ideal for implant stability, is uncommon in this area. Only about 5% of patients have a thick wall (>1mm) in the central incisor region.
- Facial Bone Defects: Another recent study found that over half (52%) of implant sites in the central incisor area have a missing facial bone wall (defect).
These findings highlight the main concerns with immediate implants in the front upper jaw:
- Bone Instability: Thin bone and missing facial bone can lead to an unstable implant, especially in the thin tissue layer at the front of the jaw (labial plate).
- Soft Tissue instability: An unstable implant can cause the gum tissue to recede, compromising the cosmetic outcome in this highly visible area. researchers like Buser et al. propose a treatment option that offers documented long-term predictability for achieving good aesthetic outcomes. This approach involves:
- Early Implant Placement (Type 2): The implant is placed shortly after tooth extraction.
- Flap Surgery: This surgical technique allows for better access to the bone for grafting.
- Guided Bone Regeneration: Bone grafting material is used to stimulate new bone growth in the missing facial bone area.
- Submerged Healing: The implant is left covered by gum tissue for a period of healing before attaching the final restoration.
This alternative approach addresses the challenges of immediate implant placement in cases with missing facial bone walls in the front upper jaw, while offering a predictable and aesthetically pleasing long-term solution.
A recent studies compared an alternative approach to the contour augmentation technique. The technique is the novel vestibular socket therapy proposed by ELaskary et al.
The findings suggest VST may be a viable option for these situations, offering comparable bone formation and improved soft tissue stability while streamlining the treatment process with fewer surgical interventions.
The study found that VST offered several advantages:
- More stable gum tissue
- Similar bone growth compared to contour augmentation
- Faster treatment time
- Fewer surgeries Overall, VST appears to be a promising alternative to contour augmentation for implant placement.
- Being tested
- vestibular socket therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular socket therapyProcedure or surgery
atraumatic extraction to the hopeless teeth will be performed using periotomes followed by conventional forceps under local anesthesia.
- Access and Socket Preparation:
- A small incision (1 cm) is made on (vestibular area) near the base of the extracted teeth, extending slightly towards neighboring teeth. This creates a pouch for accessing the socket and surrounding bone.
- Using special instruments from the VST kit, the gum tissue is carefully dissected to expose the underlying bone.
- Immediate Implant Placement with Guide:
- A prefabricated surgical guide ensures precise positioning of the implants directly into the socket.
- Bone Grafting and Membrane:
- A mixture of bone chips harvested from the surgical site (autogenous bone) and a bone-grafting material (deproteinized bovine bone mineral) is used to fill any gaps and support the implant, especially in the labial bone wall (labial plate).
- A special 0.6 mm thick membrane is inserted through the access incision. This membra
| Study group | Role | What they receive |
|---|---|---|
| control group (contour augmentation | Active comparator | Teeth extraction : minimally invasive adjacent teeth extraction under anesthesia using periotome and forceps.
the empty sockets will be filled with a special collagen material (BioPlug) to aid healing for 4 to 8 weeks.
flap elevation : a full-thickness flap will be carefully raised using a crestal incision extended one tooth mesial and distal to the extraction location, then connected with two vertical incisions extended through the sulcus forming a trapezoid flap.
Implants Insertion: The two implant is then placed into the prepared sockets using surgical guide.
Bone Grafting: Any bone deficiencies are addressed by grafting. This involves placing a layer of (autogenous bone) directly on the two implants' surface, followed by a layer of a bone-grafting material (Demineralized Bone Matrix).
Membrane Placement: A double-layered collagen membrane is used to cover the grafted area.
Flap Closure: The previously lifted flap is repositioned and sutured back in place. Receives: Procedure: vestibular socket therapy |
| study group (VST) | Active comparator | 1. Access and Socket Preparation:
* A small incision (1 cm) is made on (vestibular area) near the base of the extracted teeth, extending slightly towards neighboring teeth. This creates a pouch for accessing the socket and surrounding bone.
* Using special instruments from the VST kit.
2. Immediate Implant Placement with Guide:
* A prefabricated surgical guide ensures precise positioning of the implants directly into the socket.
3. Bone Grafting and Membrane:
* A mixture of bone chips harvested from the surgical site (autogenous bone) and a bone-grafting material (deproteinized bovine bone mineral) is used to fill any gaps and support the implant, especially in the labial bone wall (labial plate).
4. Closure and Healing:
* The small incision is stitched closed with sutures.
* A temporary healing cap is placed on the implants to facilitate proper healing. 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, 3 months postoperative and 6 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: 6 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, 3 months postoperatively and 6 months post operative. Tool to be used: cone beam computed tomography (cbct)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start25 Jun 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: amendment in study design / stopping the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant in Compromised Adjacent SocketsStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Gamaleldin ahmed youssef, BDS, Principal investigator, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673446
- Sponsor's protocol ID
- 24-049
- Status last verified
- Nov 2024
- First submitted
- 2 Nov 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Stability in the Esthetic Zone: A Randomized Clinical Trial Comparing Vestibular Socket Therapy With Contour Augmentation for Compromised Adjacent Sockets
- ClinicalTrials.gov ID
- NCT06673446
- Acronym / sponsor ID
- 24-049
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: amendment in study design / stopping the trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 5 Nov 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.
While early implant placement with guided bone regeneration (GBR) offers advantages, the desire for reduced treatment time and fewer surgical steps continues to drive the exploration of alternative approaches. In this context, the recent introduction of vestibular socket therapy (VST) presents an intriguing option. VST utilizes a minimally invasive tunnel access technique through the vestibular area to perform socket augmentation for immediate implant placement in compromised extraction sockets .
Detailed description
The concept of immediate implant placement has been around for a while. Professor Wilfried Schulte conducted the first study on this technique in 1978, Extensive studies conducted over the past 40 years have demonstrated that immediate implant placement is a safe and effective method for restoring teeth that are badly destructed.
While immediate implant placement has been shown as a viable option, new studies using advanced imaging techniques (cone beam CT scans) reveal limitations in the front upper jaw (anterior maxilla).
- Thin Bone Walls: These scans show that a thick bone wall, ideal for implant stability, is uncommon in this area. Only about 5% of patients have a thick wall (>1mm) in the central incisor region.
- Facial Bone Defects: Another recent study found that over half (52%) of implant sites in the central incisor area have a missing facial bone wall (defect).
These findings highlight the main concerns with immediate implants in the front upper jaw:
- Bone Instability: Thin bone and missing facial bone can lead to an unstable implant, especially in the thin tissue layer at the front of the jaw (labial plate).
- Soft Tissue instability: An unstable implant can cause the gum tissue to recede, compromising the cosmetic outcome in this highly visible area. researchers like Buser et al. propose a treatment option that offers documented long-term predictability for achieving good aesthetic outcomes. This approach involves:
- Early Implant Placement (Type 2): The implant is placed shortly after tooth extraction.
- Flap Surgery: This surgical technique allows for better access to the bone for grafting.
- Guided Bone Regeneration: Bone grafting material is used to stimulate new bone growth in the missing facial bone area.
- Submerged Healing: The implant is left covered by gum tissue for a period of healing before attaching the final restoration.
This alternative approach addresses the challenges of immediate implant placement in cases with missing facial bone walls in the front upper jaw, while offering a predictable and aesthetically pleasing long-term solution.
A recent studies compared an alternative approach to the contour augmentation technique. The technique is the novel vestibular socket therapy proposed by ELaskary et al.
The findings suggest VST may be a viable option for these situations, offering comparable bone formation and improved soft tissue stability while streamlining the treatment process with fewer surgical interventions.
The study found that VST offered several advantages:
- More stable gum tissue
- Similar bone growth compared to contour augmentation
- Faster treatment time
- Fewer surgeries Overall, VST appears to be a promising alternative to contour augmentation for implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group (contour augmentation | Active comparator | Procedure: vestibular socket therapyTeeth extraction : minimally invasive adjacent teeth extraction under anesthesia using periotome and forceps. the empty sockets will be filled with a special collagen material (BioPlug) to aid healing for 4 to 8 weeks. flap elevation : a full-thickness flap will be carefully raised using a crestal incision extended one tooth mesial and distal to the extraction location, then connected with two vertical incisions extended through the sulcus forming a trapezoid flap. Implants Insertion: The two implant is then placed into the prepared sockets using surgical guide. Bone Grafting: Any bone deficiencies are addressed by grafting. This involves placing a layer of (autogenous bone) directly on the two implants' surface, followed by a layer of a bone-grafting material (Demineralized Bone Matrix). Membrane Placement: A double-layered collagen membrane is used to cover the grafted area. Flap Closure: The previously lifted flap is repositioned and sutured back in place. |
| study group (VST) | Active comparator | Procedure: vestibular socket therapy1. Access and Socket Preparation: * A small incision (1 cm) is made on (vestibular area) near the base of the extracted teeth, extending slightly towards neighboring teeth. This creates a pouch for accessing the socket and surrounding bone. * Using special instruments from the VST kit. 2. Immediate Implant Placement with Guide: * A prefabricated surgical guide ensures precise positioning of the implants directly into the socket. 3. Bone Grafting and Membrane: * A mixture of bone chips harvested from the surgical site (autogenous bone) and a bone-grafting material (deproteinized bovine bone mineral) is used to fill any gaps and support the implant, especially in the labial bone wall (labial plate). 4. Closure and Healing: * The small incision is stitched closed with sutures. * A temporary healing cap is placed on the implants to facilitate proper healing. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults (20 to 50)
- patients with two adjacent hopeless maxillary teeth or remaining roots 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, thereby achieving optimum primary stability (a minimum of 30 Ncm insertion torque) following teeth extraction.
- acceptable compliance and oral hygiene.
Key exclusion criteria (2 listed)
- medically compromised patients. (Systemic diseases).
- general contraindication for implant placement. (Untreated periodontitis, severe bruxism , immunosuppression , uncontrolled diabetes , smokers , patients under radiation therapy, patients on bisphosphonate medications).
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 therapyatraumatic extraction to the hopeless teeth will be performed using periotomes followed by conventional forceps under local anesthesia. 1. Access and Socket Preparation: * A small incision (1 cm) is made on (vestibular area) near the base of the extracted teeth, extending slightly towards neighboring teeth. This creates a pouch for accessing the socket and surrounding bone. * Using special instruments from the VST kit, the gum tissue is carefully dissected to expose the underlying bone. 2. Immediate Implant Placement with Guide: * A prefabricated surgical guide ensures precise positioning of the implants directly into the socket. 3. Bone Grafting and Membrane: * A mixture of bone chips harvested from the surgical site (autogenous bone) and a bone-grafting material (deproteinized bovine bone mineral) is used to fill any gaps and support the implant, especially in the labial bone wall (labial plate). * A special 0.6 mm thick membrane is inserted through the access incision. This membra | Procedure or surgery | control group (contour augmentation, study group (VST) |
Primary outcome
Soft Tissue Stability
Time frame: 6 months
it will be measured digitally using the intraoral scanner. A preoperative scanning, immediate postoperative, 3 months postoperative and 6 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: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: Yes
Related trials for Dental Implant in Compromised Adjacent Sockets
Recruiting
Management of Multiple Adjacent Extraction Sockets
Dental Implant in Compromised Adjacent Sockets
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 Gamaleldin ahmed youssef, 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 in people with Dental Implant in Compromised Adjacent Sockets, 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 2 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: withdrawn, as of the sponsor's last update on 8 Jul 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 was withdrawn before enrolling participants, so there are no results.
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: 6 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 8 Jul 2025.