Socket PreservationRCTNCT04013425
Socket Preservation Using the Ice Cream Cone Technique Versus Spontaneous Healing in Fresh Extraction Sockets.
A study testing Ice Cream Cone Technique in people with Socket Preservation, run by Cairo University at 1 site in Egypt.
Trial summary
The research is about socket preservation using the ice cream cone technique including collagen membrane and xenograft compared to spontaneous healing. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Socket Preservation
- What is being tested?
- Ice Cream Cone Technique
- 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
- Aug 2019to Jul 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Single or double rooted teeth indicated for extraction
- Presence of a buccal defect.
- Maxillary and Mandibular Arches
Who cannot join
- Systemic conditions/disease that contraindicated surgery.
- Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
- Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
- Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Andrew George
Cairo, 11451
Andrew George, +201270151119, drewgeorge90@gmail.com
drewgeorge90@gmail.com
About this study
The research is about socket preservation using the ice cream cone technique including collagen membrane and xenograft compared to spontaneous healing.
Read the detailed description
Atraumatic extraction is done and the socket is either left for spontaneous healing or the ice cream cone technique using the collagen membrane and the socket is filled with xenograft.
- Conditions
- Socket Preservation
- Being tested
- Ice Cream Cone Technique
- Keywords
- Socket preservation, Alveolar Ridge Preservation, Ridge Preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice Cream Cone TechniqueProcedure or surgery
Guided bone regeneration
| Study group | Role | What they receive |
|---|---|---|
| Ice Cream Cone Technique | Experimental | Atraumatic extraction followed by addition of barrier membrane and xenograft in the socket. Receives: Procedure: Ice Cream Cone Technique |
| Spontaneous Healing | No intervention | Spontaneous Healing after Atraumatic Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal Bone Dimension from the CBCT in mm.
from the CBCT in mm.
Measured: 3 months
Secondary outcomes (2)
Buccal Vertical Bone Dimension
from CBCT in mm.
Measured: 3 months
Palatal Vertical Bone Dimension
from CBCT in mm.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionJul 2020 (estimated)
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 Socket PreservationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew George Edward Aziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013425
- Sponsor's protocol ID
- Philo new protocol
- Acronym
- RCT
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tan-Chu JH, Tuminelli FJ, Kurtz KS, Tarnow DP. Analysis of buccolingual dimensional changes of the extraction socket using the "ice cream cone" flapless grafting technique. Int J Periodontics Restorative Dent. 2014 May-Jun;34(3):399-403. doi: 10.11607/prd.1605.
PubMed 24804291
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socket Preservation Using the Ice Cream Cone Technique Versus Spontaneous Healing in Fresh Extraction Sockets.
- ClinicalTrials.gov ID
- NCT04013425
- Acronym / sponsor ID
- RCT / Philo new protocol
- Conditions
- Socket Preservation
- Keywords
- Socket preservation, Alveolar Ridge Preservation, Ridge Preservation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 9 Jul 2019 (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.
The research is about socket preservation using the ice cream cone technique including collagen membrane and xenograft compared to spontaneous healing.
Detailed description
Atraumatic extraction is done and the socket is either left for spontaneous healing or the ice cream cone technique using the collagen membrane and the socket is filled with xenograft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ice Cream Cone Technique | Experimental | Procedure: Ice Cream Cone TechniqueAtraumatic extraction followed by addition of barrier membrane and xenograft in the socket. |
| Spontaneous Healing | No intervention | –Spontaneous Healing after Atraumatic Extraction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Single or double rooted teeth indicated for extraction
- Presence of a buccal defect.
- Maxillary and Mandibular Arches
Key exclusion criteria (4 listed)
- Systemic conditions/disease that contraindicated surgery.
- Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
- Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
- Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
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 TechniqueGuided bone regeneration | Procedure or surgery | Ice Cream Cone Technique |
Primary outcome
Horizontal Bone Dimension from the CBCT in mm.
Time frame: 3 months
from the CBCT in mm.
2 secondary outcomes
Buccal Vertical Bone Dimension
Time frame: 3 months
Palatal Vertical Bone Dimension
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Results publication: PubMed 24804291Tan-Chu JH, Tuminelli FJ, Kurtz KS, Tarnow DP. Analysis of buccolingual dimensional changes of the extraction socket using the "ice cream cone" flapless grafting technique. Int J Periodontics Restorative Dent. 2014 May-Jun;34(3):399-403. doi: 10.11607/prd.1605.
- Individual participant dataSharing planned: Undecided
Related trials for Socket Preservation
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Recruiting
Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Surgery, Oral
RecruitingPhase 4
Biotivity A-C Membrane Socket Preservation Study
Alveolar Ridge Preservation
Active, not recruiting
Vallomix Socket Preservation Study
Alveolar Ridge Augmentation
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice Cream Cone Technique in people with Socket Preservation, run by Cairo 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 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: status not confirmed, as of the sponsor's last update on 9 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew George (+201270151119, drewgeorge90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal Bone Dimension from the CBCT in mm. (time frame: 3 months). 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 NCT04013425, 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 9 Jul 2019.