Dental ImplantNCT04679766
Evaluation of Ice Cream Cone Technique With Immediate Implant Placement in Patients With Labial Plate Dehiscence
A study testing Ice cream cone technique with immediate implant as a flapless bone regenerative method in management of patients with labial plte dehiscence in people with Dental Implant and Guided Bone Regeneration, run by Cairo University.
Trial summary
Immediate tooth replacement with immediate implants into fresh extraction sockets has become a common and promising clinical procedure in daily practice in regard of implant survival, osseointegration and esthetic outcomes . Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Guided Bone Regeneration
- What is being tested?
- Ice cream cone technique with immediate implant as a flapless bone regenerative method in management of patients with labial plte dehiscence
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jul 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-restorable teeth in maxillary inter-bicuspid region.
- All teeth have labial plate dehiscence (socket type II) after extraction.
- Patients free from any systemic conditions that may affect healing.
- Adequate bone volume for the placement of immediate implant.
- Presence of the adjacent teeth.
- Compliant patients.
Who cannot join
- Smokers.
- Pregnant females.
- Patients who were taking or currently taking any of the bisphosphonates.
- Any disease that might affect bone metabolism as osteoporosis.
- Insufficient inter-occlusal distance or mesio-distal space to place an implant supported restoration.
- The presence of any signs of acute infection in the surgical site or the adjacent natural teeth.
About this study
Official title: Evaluation of Ice Cream Cone Technique as a Flapless Guided Bone Regenerative Method With Immediate Implant Placement in Management of Patients With Labial Plate Dehiscence: A Case Series
Immediate tooth replacement with immediate implants into fresh extraction sockets has become a common and promising clinical procedure in daily practice in regard of implant survival, osseointegration and esthetic outcomes . However, there are some challenges encountered in the treatment of patients with labial bone plate dehiscence. Deficiency of facial bone anatomy has a negative impact on esthetics and is a critical causative factor for esthetic implant complications and failures ..
Few studies investigated the reconstitution of labial bone plate dehiscence using ice cream cone technique and their results showed adequate bone regeneration 4 to 6 months where no labial plate was present prior to grafting technique. Ice cream cone technique as a flapless grafting technique in conjunction with immediate implant placement in patients with labial bone plate dehiscence requires further studies for its clinical relevance and approval.
Read the detailed description
Classical methods of guided bone regenerative methods succeeded to partially reconstitute the lost labial plate of bone using different grafting materials with barrier membranes.
This might be attributed to the necessity of using a full mucoperiosteal flap which interrupts the vascular supply to the bone and jeopardizing the process of total facial bone regenerative process. Therefore, Tan-Chu et al., (2014) described in a case report an innovative technique using resorbable collagen membrane in the shape of ice cream cone and allograft in the reconstitution of labial plate in patients with socket type II after extraction with folding the membrane to seal the socket and containing the blood clot to allow for occupation of osteogenic cell population without raising a flap. This technique showed an adequate bone regeneration with net result of 1.32 mm prior to no labial plate present before grafting. Hence, using immediate implant placement with the conjunction of the ice cream cone technique in regeneration of labial plate of bone needs to be further assessed to evaluate its clinical outcomes.
- Conditions
- Dental Implant, Guided Bone Regeneration
- Being tested
- Ice cream cone technique with immediate implant as a flapless bone regenerative method in management of patients with labial plte dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice cream cone technique with immediate implant as a flapless bone regenerative method in management of patients with labial plte dehiscenceProcedure or surgery
Atraumatic extraction will be done The extraction socket will be debrided to remove any residual debris using surgical curettes Socket walls will be checked using a periodontal probe to ensure integrity of all sockets walls except the labial bone plate which must show a dehiscence. Implant placement will be done. All implants will engage at least 3 mm apical to the apical end of the socket with adequate primary stability Resorbable collagen membrane will be cut confirming to the size and shape of the defect of labial bone plate dehiscence. The membrane will be placed against internal surface of the extraction socket against the remaining buccal plate of bone. The gap between the collagen membrane and the implant fixture will be filled with xenograft particulates.The membrane will be folded in palatal direction to seal the socket in an ice cream cone shape, then will be secured using non-resorbable sutures
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-restorable tooth in maxillary bi-cuspid region with labial/buccal plate dehiscence | Experimental | Not described Receives: Procedure: Ice cream cone technique with immediate implant as a flapless bone regenerative method in management of patients with labial plte dehiscence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in buccal/labial vertical bone dimensions
Vertical bone dimension will be measured at day 0 and 6 months post-operative
Measured: 6 months post operative
Secondary outcomes (5)
Changes in labial/buccal plate thickness
Measured at day 0 and 6 months post-operative using Cone beam tomography
Measured: 6 months
Keratinized tissue width
Measured using william's graduated probe
Measured: 6 months
Gingival thickness
Measured using william's graduated probe
Measured: 6 months
Post operative pain measured with VAS scale
VAS scale from 0 to 10, where 0 no pain and 10 with highest pain
Measured: 1 week -2 weeks
Post-operative patient satisfaction with Yes or No question
Yes or No question of overall patient satisfaction of the procedure
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 posted22 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Amagad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679766
- Sponsor's protocol ID
- MAmagad
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, informed consent and clinical study report
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ice Cream Cone Technique as a Flapless Guided Bone Regenerative Method With Immediate Implant Placement in Management of Patients With Labial Plate Dehiscence: A Case Series
- ClinicalTrials.gov ID
- NCT04679766
- Acronym / sponsor ID
- MAmagad
- Conditions
- Dental Implant, Guided Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 22 Dec 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.
Immediate tooth replacement with immediate implants into fresh extraction sockets has become a common and promising clinical procedure in daily practice in regard of implant survival, osseointegration and esthetic outcomes . However, there are some challenges encountered in the treatment of patients with labial bone plate dehiscence. Deficiency of facial bone anatomy has a negative impact on esthetics and is a critical causative factor for esthetic implant complications and failures ..
Few studies investigated the reconstitution of labial bone plate dehiscence using ice cream cone technique and their results showed adequate bone regeneration 4 to 6 months where no labial plate was present prior to grafting technique. Ice cream cone technique as a flapless grafting technique in conjunction with immediate implant placement in patients with labial bone plate dehiscence requires further studies for its clinical relevance and approval.
Detailed description
Classical methods of guided bone regenerative methods succeeded to partially reconstitute the lost labial plate of bone using different grafting materials with barrier membranes.
This might be attributed to the necessity of using a full mucoperiosteal flap which interrupts the vascular supply to the bone and jeopardizing the process of total facial bone regenerative process. Therefore, Tan-Chu et al., (2014) described in a case report an innovative technique using resorbable collagen membrane in the shape of ice cream cone and allograft in the reconstitution of labial plate in patients with socket type II after extraction with folding the membrane to seal the socket and containing the blood clot to allow for occupation of osteogenic cell population without raising a flap. This technique showed an adequate bone regeneration with net result of 1.32 mm prior to no labial plate present before grafting. Hence, using immediate implant placement with the conjunction of the ice cream cone technique in regeneration of labial plate of bone needs to be further assessed to evaluate its clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with non-restorable tooth in maxillary bi-cuspid region with labial/buccal plate dehiscence | Experimental | Procedure: Ice cream cone technique with immediate implant as a flapless bone regenerative method in management of patients with labial plte dehiscence |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-restorable teeth in maxillary inter-bicuspid region.
- All teeth have labial plate dehiscence (socket type II) after extraction.
- Patients free from any systemic conditions that may affect healing.
- Adequate bone volume for the placement of immediate implant.
- Presence of the adjacent teeth.
Key exclusion criteria (6 listed)
- Smokers.
- Pregnant females.
- Patients who were taking or currently taking any of the bisphosphonates.
- Any disease that might affect bone metabolism as osteoporosis.
- Insufficient inter-occlusal distance or mesio-distal space to place an implant supported restoration.
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 |
|---|---|---|
| Ice cream cone technique with immediate implant as a flapless bone regenerative method in management of patients with labial plte dehiscenceAtraumatic extraction will be done The extraction socket will be debrided to remove any residual debris using surgical curettes Socket walls will be checked using a periodontal probe to ensure integrity of all sockets walls except the labial bone plate which must show a dehiscence. Implant placement will be done. All implants will engage at least 3 mm apical to the apical end of the socket with adequate primary stability Resorbable collagen membrane will be cut confirming to the size and shape of the defect of labial bone plate dehiscence. The membrane will be placed against internal surface of the extraction socket against the remaining buccal plate of bone. The gap between the collagen membrane and the implant fixture will be filled with xenograft particulates.The membrane will be folded in palatal direction to seal the socket in an ice cream cone shape, then will be secured using non-resorbable sutures | Procedure or surgery | Patients with non-restorable tooth in maxillary bi-cuspid region with labial/buccal plate dehiscence |
Primary outcome
Changes in buccal/labial vertical bone dimensions
Time frame: 6 months post operative
Vertical bone dimension will be measured at day 0 and 6 months post-operative
5 secondary outcomes
Changes in labial/buccal plate thickness
Time frame: 6 months
Keratinized tissue width
Time frame: 6 months
Gingival thickness
Time frame: 6 months
Post operative pain measured with VAS scale
Time frame: 1 week -2 weeks
Post-operative patient satisfaction with Yes or No question
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Yes. Study protocol, informed consent and clinical study report
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ice cream cone technique with immediate implant as a flapless bone regenerative method in management of patients with labial plte dehiscence in people with Dental Implant and Guided Bone Regeneration, run by Cairo University.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Changes in buccal/labial vertical bone dimensions (time frame: 6 months post operative). 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 29 Dec 2020.