Autogenous Tooth Bone GraftNCT04795102
Effect of "Autogenous Leukocyte Platelet Rich Fibrin- Tooth Graft" Combination Around Immediately Placed Implants
A study testing immediate implant placement with ATBG and L-PRF and immediate implant placement with ATBG in people with Autogenous Tooth Bone Graft and Immediate Implant Placement, run by Dalia Rasheed Issa at 1 site in Egypt.
Trial summary
Immediate implant placement into fresh extraction sockets is gaining popularity because of fewer clinical procedures and maintenance of bone architecture compared to conventional methods, thus reducing the treatment time and increasing patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Autogenous Tooth Bone Graft, Immediate Implant Placement, L-PRF
- What is being tested?
- immediate implant placement with ATBG and L-PRF and immediate implant placement with ATBG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 2 Apr 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Teeth need to be extracted for periodontal reasons with a defect of labial bone (horizontal or vertical bone defect).
- the teeth without acute inflammation.
- no uncontrolled systemic disease which is not suitable for implantation.
- Good systemic and oral health.
Who cannot join
- patients with systemic diseases or medications known to alter healing processes
- Psychiatric disorders.
- Root canal treated teeth.
- patients undergoing or who had undergone radiation therapy and chemotherapy to the head and neck region during 12 months.
- patients with para-functional habits.
- alcoholics.
- drug abusers.
- heavy smokers
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Kafrelsheikh University
Kafr ash Shaykh, 33511
About this study
Official title: Effect of "Autogenous Leukocyte Platelet Rich Fibrin- Tooth Graft" Combination Around Immediately Placed Implants in Periodontally Compromized Sites: A Randomized Clinical Trial
Immediate implant placement into fresh extraction sockets is gaining popularity because of fewer clinical procedures and maintenance of bone architecture compared to conventional methods, thus reducing the treatment time and increasing patient satisfaction. In addition, the survival rate of the immediate implantation is comparable to that of the healed implantation sites. Recently, ATBG made from compromised teeth was applied in bone defects and resulted in a good clinical efficacy. Moreover, it is more accepted by patients to use extracted teeth as a bone graft material, especially in the case of immediate implant placement. In 2020, Kizildağ and coworkers studied the outcome of PRF as an adjunct with ATBG on bone healing in rabbit peri-implant osseous defects. They reported that combination of ATBG with PRF contributed to significantly higher new bone formation and better bone/implant contact in rabbits with peri-implant bone defects. The main hypothesis behind this study is that using L-PRF with ATBG following immediate implant placement could promote stabilization of graft particles and enhance new bone formation with a shorter time. Therefore, the purpose of this study was to compare the clinical and radiographic outcomes of ATBG on bone formation with or without L-PRF around immediately placed dental implants in periodontally compromised teeth.
- Being tested
- immediate implant placement with ATBG and L-PRF, immediate implant placement with ATBG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant placement with ATBG and L-PRFCombination product
immediate implant placement using ATBG as a graft material, with L-PRF
immediate implant placement with ATBGCombination product
immediate implant placement using ATBG as a graft material without L-PRF
| Study group | Role | What they receive |
|---|---|---|
| L-PRF with ATBG around implant | Experimental | L-PRF clots to cover ATBG around immediately placed dental implants in the extraction sockets Receives: Combination Product: immediate implant placement with ATBG and L-PRF |
| ATBG around implant | Active comparator | ATBG around immediately placed dental implants in the extraction sockets Receives: Combination Product: immediate implant placement with ATBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evaluation of bone formation around immediately placed dental implants
Changes on bone formation using ATBG with or without L-PRF around immediately placed dental implants in periodontally compromised teeth
Measured: 9 months
radiographic outcome around immediately placed dental implants
the radiographic outcome of ATBG on bone formation with or without L-PRF around immediately placed dental implants in periodontally compromised teeth
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Jan 2020
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autogenous Tooth Bone GraftStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalia Rasheed Issa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dalia Rasheed Issa, Kafrelsheikh University
- Investigators
- Dalia R Issa, PhD, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795102
- Sponsor's protocol ID
- KD/03/20
- Status last verified
- Sep 2021
- First submitted
- 7 Mar 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of "Autogenous Leukocyte Platelet Rich Fibrin- Tooth Graft" Combination Around Immediately Placed Implants in Periodontally Compromized Sites: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04795102
- Acronym / sponsor ID
- KD/03/20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dalia Rasheed IssaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 12 Mar 2021 (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 implant placement into fresh extraction sockets is gaining popularity because of fewer clinical procedures and maintenance of bone architecture compared to conventional methods, thus reducing the treatment time and increasing patient satisfaction. In addition, the survival rate of the immediate implantation is comparable to that of the healed implantation sites. Recently, ATBG made from compromised teeth was applied in bone defects and resulted in a good clinical efficacy. Moreover, it is more accepted by patients to use extracted teeth as a bone graft material, especially in the case of immediate implant placement. In 2020, Kizildağ and coworkers studied the outcome of PRF as an adjunct with ATBG on bone healing in rabbit peri-implant osseous defects. They reported that combination of ATBG with PRF contributed to significantly higher new bone formation and better bone/implant contact in rabbits with peri-implant bone defects. The main hypothesis behind this study is that using L-PRF with ATBG following immediate implant placement could promote stabilization of graft particles and enhance new bone formation with a shorter time. Therefore, the purpose of this study was to compare the clinical and radiographic outcomes of ATBG on bone formation with or without L-PRF around immediately placed dental implants in periodontally compromised teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-PRF with ATBG around implant | Experimental | Combination Product: immediate implant placement with ATBG and L-PRFL-PRF clots to cover ATBG around immediately placed dental implants in the extraction sockets |
| ATBG around implant | Active comparator | Combination Product: immediate implant placement with ATBGATBG around immediately placed dental implants in the extraction sockets |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Teeth need to be extracted for periodontal reasons with a defect of labial bone (horizontal or vertical bone defect).
- the teeth without acute inflammation.
- no uncontrolled systemic disease which is not suitable for implantation.
- Good systemic and oral health.
Key exclusion criteria (8 listed)
- patients with systemic diseases or medications known to alter healing processes
- Psychiatric disorders.
- Root canal treated teeth.
- patients undergoing or who had undergone radiation therapy and chemotherapy to the head and neck region during 12 months.
- patients with para-functional habits.
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 placement with ATBG and L-PRFimmediate implant placement using ATBG as a graft material, with L-PRF | Combination product | L-PRF with ATBG around implant |
| immediate implant placement with ATBGimmediate implant placement using ATBG as a graft material without L-PRF | Combination product | ATBG around implant |
Primary outcome
clinical evaluation of bone formation around immediately placed dental implants
Time frame: 9 months
Changes on bone formation using ATBG with or without L-PRF around immediately placed dental implants in periodontally compromised teeth
radiographic outcome around immediately placed dental implants
Time frame: 9 months
the radiographic outcome of ATBG on bone formation with or without L-PRF around immediately placed dental implants in periodontally compromised teeth
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 2 Sep 2021.
Related trials for Autogenous Tooth Bone Graft
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L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
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Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
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Evaluation of Autogenous Bone Graft on Immediate Dental Implant Osseointegration Using Piezosurgery
Tooth Loss, Partial Edentulism in the Maxilla or in the Mandible
Enrolling by invitation
Evaluation of Clinical and Radiological Outcomes Following the Treatment of Periodontal Intraosseous Defects Using Autogenous Tooth-derived Graft or Autogenous Bone Graft With Enamel Matrix Derivatives. A 12-month Randomized Controlled Clinical Trial.
Periodontitis
Active, not recruiting
Autogenous Tooth Bone Graft for Alveolar Socket Preservation
Alveolar Bone Grafting, Bone Regeneration Following Wisdom Teeth Extraction
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.
Dalia R Issa, PhD principal investigator
Kafrelsheikh University
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 placement with ATBG and L-PRF and immediate implant placement with ATBG in people with Autogenous Tooth Bone Graft and Immediate Implant Placement, run by Dalia Rasheed Issa 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 4 inclusion and 8 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 2 Sep 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?
clinical evaluation of bone formation around immediately placed dental implants (time frame: 9 months). The study lists 2 primary outcomes in all. 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 2 Sep 2021.