Socket PreservationEarly Phase 1NCT03677479
Evaluation of Post-extraction Socket Preservation With Camelline Versus Bovine Deproteinized Xenograft
A Early Phase 1 study testing socket preservation procedure in people with Socket Preservation, run by Cairo University.
Trial summary
Alveolar ridge preservation following tooth extraction has the ability to maintain the ridge dimensions and allow the implant placement in an ideal position fulfilling both functional and aesthetic results. Postextraction socket healing commonly results in resorption of the alveolar ridge. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Socket Preservation
- What is being tested?
- socket preservation procedure
- 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
- Mar 2019to Aug 2020
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Teeth with: root fractures, endodontic treatment failures, advanced caries lesions or any other cause that make tooth non-restorable and indicated for extraction.
- Healthy non-smoker patients
Who cannot join
- Medically compromised patients.
- Pregnant females.
- History of malignancy or radiotherapy/chemotherapy for malignancy in the past 5 years.
- History of active bone metabolic disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Post-extraction Socket Preservation With Camelline Versus Bovine Deproteinized Xenograft (Pilot Trial)
Alveolar ridge preservation following tooth extraction has the ability to maintain the ridge dimensions and allow the implant placement in an ideal position fulfilling both functional and aesthetic results. Postextraction socket healing commonly results in resorption of the alveolar ridge.
To prevent this clinical situation, different authors have described several surgical procedures, ranging from regenerative techniques for socket preservation to immediate implant placement. Regenerative techniques have been widely tested in controlled and uncontrolled studies with various materials and clinical approaches: bone grafting alone, including autografts, allografts, xenografts, and alloplasts; membrane alone, whether absorbable or not; and membrane in conjunction with grafting.
Read the detailed description
Various classic studies in the 1960s showed that the resorption process of the postextraction alveolus in both jaws was significantly more pronounced on the buccal aspect. This comes as no surprise, as the buccal surface of the anterior alveolar ridge is commonly thin and fragile. The maxilla tends to exhibit greater reductions in width than in height. The loss of tissue contour takes place mostly during the first 1 to 3 months following tooth extraction. Because the healing patterns of human sockets are unpredictable architecture), then such common procedures as extractions may lead to intraoral situations in which the remaining healed ridge does not allow for an esthetic and functional solution without the aid of significant bone grafting.
- Conditions
- Socket Preservation
- Being tested
- socket preservation procedure
- Keywords
- bone grafts, xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socket preservation procedureProcedure or surgery
Also called alveolar ridge preservation
socket preservation of post extraction site using bone xenografts
| Study group | Role | What they receive |
|---|---|---|
| socket preservation with camelline bone | Experimental | natural hydroxyapatite derived from camels prepared by investigator Receives: Procedure: socket preservation procedure |
| socket preservation with bovine bone | Active comparator | natural hydroxyapatite derived from cows (Bio-Oss) Receives: Procedure: socket preservation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-reported outcome
assessment of post-operative complication( pain, swelling, bleeding, infection)
Measured: within first week postoperatively
Secondary outcomes (1)
ridge contour changes
dimentional changes after extraction and socket preservation
Measured: 3 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study startMar 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionAug 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilot randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Adayil, Cairo University
- Investigators
- Manal Hosny, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677479
- Sponsor's protocol ID
- PER123
- Status last verified
- Jan 2019
- First submitted
- 18 Sep 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: check with university guidelines for raw data sharing
Publications
Chang PC, Chang HC, Lin TC, Tai WC. Preclinical alveolar ridge preservation using small-sized particles of bone replacement graft in combination with a gelatin cryogel scaffold. J Periodontol. 2018 Oct;89(10):1221-1229. doi: 10.1002/JPER.17-0629. Epub 2018 Aug 29.
PubMed 30039627
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-extraction Socket Preservation With Camelline Versus Bovine Deproteinized Xenograft (Pilot Trial)
- ClinicalTrials.gov ID
- NCT03677479
- Acronym / sponsor ID
- PER123
- Conditions
- Socket Preservation
- Keywords
- bone grafts, xenograft
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 19 Sep 2018 (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.
Alveolar ridge preservation following tooth extraction has the ability to maintain the ridge dimensions and allow the implant placement in an ideal position fulfilling both functional and aesthetic results. Postextraction socket healing commonly results in resorption of the alveolar ridge.
To prevent this clinical situation, different authors have described several surgical procedures, ranging from regenerative techniques for socket preservation to immediate implant placement. Regenerative techniques have been widely tested in controlled and uncontrolled studies with various materials and clinical approaches: bone grafting alone, including autografts, allografts, xenografts, and alloplasts; membrane alone, whether absorbable or not; and membrane in conjunction with grafting.
Detailed description
Various classic studies in the 1960s showed that the resorption process of the postextraction alveolus in both jaws was significantly more pronounced on the buccal aspect. This comes as no surprise, as the buccal surface of the anterior alveolar ridge is commonly thin and fragile. The maxilla tends to exhibit greater reductions in width than in height. The loss of tissue contour takes place mostly during the first 1 to 3 months following tooth extraction. Because the healing patterns of human sockets are unpredictable architecture), then such common procedures as extractions may lead to intraoral situations in which the remaining healed ridge does not allow for an esthetic and functional solution without the aid of significant bone grafting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- pilot randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| socket preservation with camelline bone | Experimental | Procedure: socket preservation procedurenatural hydroxyapatite derived from camels prepared by investigator |
| socket preservation with bovine bone | Active comparator | Procedure: socket preservation procedurenatural hydroxyapatite derived from cows (Bio-Oss) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Teeth with: root fractures, endodontic treatment failures, advanced caries lesions or any other cause that make tooth non-restorable and indicated for extraction.
- Healthy non-smoker patients
Key exclusion criteria (4 listed)
- Medically compromised patients.
- Pregnant females.
- History of malignancy or radiotherapy/chemotherapy for malignancy in the past 5 years.
- History of active bone metabolic disease.
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 |
|---|---|---|
| socket preservation procedureAlso: alveolar ridge preservationsocket preservation of post extraction site using bone xenografts | Procedure or surgery | socket preservation with bovine bone, socket preservation with camelline bone |
Primary outcome
patient-reported outcome
Time frame: within first week postoperatively
assessment of post-operative complication( pain, swelling, bleeding, infection)
1 secondary outcome
ridge contour changes
Time frame: 3 month, 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Results publication: PubMed 30039627Chang PC, Chang HC, Lin TC, Tai WC. Preclinical alveolar ridge preservation using small-sized particles of bone replacement graft in combination with a gelatin cryogel scaffold. J Periodontol. 2018 Oct;89(10):1221-1229. doi: 10.1002/JPER.17-0629. Epub 2018 Aug 29.
- Individual participant dataSharing planned: Undecided. check with university guidelines for raw data sharing
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.
Manal Hosny, PhD study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing socket preservation procedure in people with Socket Preservation, 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 2 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 31 Jan 2019. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ghada Adayil, Msc ((+202)01006010412, ghada.adayil@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient-reported outcome (time frame: within first week postoperatively). 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 NCT03677479, 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 31 Jan 2019.