Crestal Bone LossNCT03544580
Soft Tissue Esthetic With Autogenous Dentin Chips and Immediate Implantation Versus Conventional Immediate Implantation With Xenograft in Thin Buccal Bone
A study testing immediate implant with dentine chips and conventional immediate implant in people with Crestal Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
After tooth extraction, host bone resorption and atrophy of alveolar ridge may be observed. Bone resorption occurs specially in incisors and premolar area of jaw in region of thin buccal bone that may lead to change in contour. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Crestal Bone Loss
- What is being tested?
- immediate implant with dentine chips and conventional immediate implant
- 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
- 1 Aug 2018to 30 Dec 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient related :
- Patient who only need to restore this single tooth.
- Good oral hygiene
- Systemically healthy (free from any systemic diseases)
- Site related :
- Hopeless tooth (nonrestorable, badly broken, endodontically treated) indicated for extraction and immediate implant placement
- Esthetic area with thin buccal bone
- Having periapical bone more than 3mm for primary stability
Who cannot join
- Patient related :
- Smokers
- Pregnant woman
- Site related
- Teeth that have to be extracted due to advanced periodontal bone loss
- Trauma in aesthetic area
- Periapical infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soft Tissue Esthetic With Autogenous Dentin Chips and Immediate Implantation Versus Conventional Immediate Implantation With Xenograft in Thin Buccal Bone: (Randomized Controlled Clinical Trial )
After tooth extraction, host bone resorption and atrophy of alveolar ridge may be observed. Bone resorption occurs specially in incisors and premolar area of jaw in region of thin buccal bone that may lead to change in contour. Total clinical bone loss height approximately 2-5 mm at first 6 months may be observed in vertical dimension , after 12 months alveolar ridge may lose up to 50 % of its width.
Read the detailed description
Recently augmentation with bone grafting became one of the most common techniques surgically ; progressive bone resorption may be prevented by using augmentation procedures with use of graft materials. The gold standard in regenerative procedures is autogenous bone graft because of osteoinduction , osteoconduction and osteointergration properties required in regeneration. In autogenous bone graft there is need for a second surgical site , donor site morbidity and limited availability will lead to challenge for alternative bio-materials.
Extracted healthy non functional teeth from human are considered to be a dental waste all over the world. High proportion of extracted sockets are left untreated for physiological healing. Inadequate or failure of bone healing in sockets has been seen due to absence of bone graft material. Stem cells, matrix , trace metal ions and growth factors are rich in human tooth. Bone and dentin tissue structure are different but ratio of components is similar (mineral 70% , collagen 20% and body fluid 10% by weight). Dentin after demineralization is mainly composed of type 1 collagen 95% and non collagenous proteins as growth factors.
- Conditions
- Crestal Bone Loss
- Being tested
- immediate implant with dentine chips, conventional immediate implant
- Keywords
- dentin, immediate implant, buccal bone resorption, crestal bone loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant with dentine chipsProcedure or surgery
Also called Conventional immediate implantation
Using dentin chips
conventional immediate implantProcedure or surgery
Also called immediate implantation with xenograft
using xenograft
| Study group | Role | What they receive |
|---|---|---|
| immediate implant with dentin chips | Experimental | using the tooth structure presented in socket either as remaining root or as unrestorable tooth structure remove all periodontal ligaments \& scraping all enamel \& cementum using a stone also to cut it into slices then putting it in acid to demineralize the dentine ; then using a bone mill to transform dentine into small particles or chips to be used in jumping gap between implant \& thin buccal bone Receives: Procedure: immediate implant with dentine chips |
| immediate implant with xenograft | Active comparator | after surgical removal of entire badly decayed tooth we immediately put implant and in jumping gap we use xenograft Receives: Procedure: conventional immediate implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue esthetics
pink esthetic score will be taken by photos from the day of surgery till 12 months postoperatively.
The PES will evaluate the mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/ soft tissue color and texture at the facial aspect of the implant site as five variables. A score of 2, 1, or 0 is assigned to each of five PES parameters. Thus, in case of an implant restoration, a maximum total PES of 10 is possible
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Aug 2018
- Primary completion30 Oct 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crestal Bone LossStudies 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
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cherine Emad Mahmoud Mohamed Hamada, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544580
- Sponsor's protocol ID
- CEBD-CU-2018-05-01
- Status last verified
- Apr 2021
- First submitted
- 7 May 2018
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Esthetic With Autogenous Dentin Chips and Immediate Implantation Versus Conventional Immediate Implantation With Xenograft in Thin Buccal Bone: (Randomized Controlled Clinical Trial )
- ClinicalTrials.gov ID
- NCT03544580
- Acronym / sponsor ID
- CEBD-CU-2018-05-01
- Conditions
- Crestal Bone Loss
- Keywords
- dentin, immediate implant, buccal bone resorption, crestal bone loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 4 Jun 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.
After tooth extraction, host bone resorption and atrophy of alveolar ridge may be observed. Bone resorption occurs specially in incisors and premolar area of jaw in region of thin buccal bone that may lead to change in contour. Total clinical bone loss height approximately 2-5 mm at first 6 months may be observed in vertical dimension , after 12 months alveolar ridge may lose up to 50 % of its width.
Detailed description
Recently augmentation with bone grafting became one of the most common techniques surgically ; progressive bone resorption may be prevented by using augmentation procedures with use of graft materials. The gold standard in regenerative procedures is autogenous bone graft because of osteoinduction , osteoconduction and osteointergration properties required in regeneration. In autogenous bone graft there is need for a second surgical site , donor site morbidity and limited availability will lead to challenge for alternative bio-materials.
Extracted healthy non functional teeth from human are considered to be a dental waste all over the world. High proportion of extracted sockets are left untreated for physiological healing. Inadequate or failure of bone healing in sockets has been seen due to absence of bone graft material. Stem cells, matrix , trace metal ions and growth factors are rich in human tooth. Bone and dentin tissue structure are different but ratio of components is similar (mineral 70% , collagen 20% and body fluid 10% by weight). Dentin after demineralization is mainly composed of type 1 collagen 95% and non collagenous proteins as growth factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate implant with dentin chips | Experimental | Procedure: immediate implant with dentine chipsusing the tooth structure presented in socket either as remaining root or as unrestorable tooth structure remove all periodontal ligaments \& scraping all enamel \& cementum using a stone also to cut it into slices then putting it in acid to demineralize the dentine ; then using a bone mill to transform dentine into small particles or chips to be used in jumping gap between implant \& thin buccal bone |
| immediate implant with xenograft | Active comparator | Procedure: conventional immediate implantafter surgical removal of entire badly decayed tooth we immediately put implant and in jumping gap we use xenograft |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patient related :
- Hopeless tooth (nonrestorable, badly broken, endodontically treated) indicated for extraction and immediate implant placement
- Esthetic area with thin buccal bone
- Having periapical bone more than 3mm for primary stability
Key exclusion criteria (7 listed)
- Patient related :
- Site related
- Teeth that have to be extracted due to advanced periodontal bone loss
- Trauma in aesthetic area
- Periapical infection.
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 |
|---|---|---|
| immediate implant with dentine chipsAlso: Conventional immediate implantationUsing dentin chips | Procedure or surgery | immediate implant with dentin chips |
| conventional immediate implantAlso: immediate implantation with xenograftusing xenograft | Procedure or surgery | immediate implant with xenograft |
Primary outcome
Soft tissue esthetics
Time frame: 12 months
pink esthetic score will be taken by photos from the day of surgery till 12 months postoperatively. The PES will evaluate the mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/ soft tissue color and texture at the facial aspect of the implant site as five variables. A score of 2, 1, or 0 is assigned to each of five PES parameters. Thus, in case of an implant restoration, a maximum total PES of 10 is possible
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 27 Apr 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate implant with dentine chips and conventional immediate implant in people with Crestal Bone Loss, 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 8 inclusion and 7 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 27 Apr 2021. 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 esthetics (time frame: 12 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 27 Apr 2021.