Immediate ImplantNCT05878392
Immediate Implant With Different Filling Materials
A study testing bone filling materials in people with Immediate Implant, run by Mansoura University at 1 site in Egypt.
Trial summary
36 patients, were included in this study. They were chosen from the Outpatient Clinic in the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable maxillary anterior and premolar teeth (esthetic zone) by immediate implant. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant
- What is being tested?
- bone filling materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jan 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient medically free from systemic diseases.
- Age above 18 years.
- A single maxillary anterior or premolar tooth that cannot be restored.
- No acute infection is present.
- Patients with sufficient quality and quantity of bone.
- Free from history of bruxism.
Who cannot join
- A medical condition that would prevent implant surgery.
- Existence of non-treated generalized progressive periodontitis.
- Patients who are smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Different Filling Materials in Immediate Implant
36 patients, were included in this study. They were chosen from the Outpatient Clinic in the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable maxillary anterior and premolar teeth (esthetic zone) by immediate implant.
- Conditions
- Immediate Implant
- Being tested
- bone filling materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone filling materialsOther
the buccal jumping gap was packed using PRF in group 1 the buccal jumping gap was packed using xenograft in group 2 the buccal jumping gap was packed using Alloplastic β-tricalcium phosphate in group 3
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | immediate implant placement and the buccal jumping gap was packed using PRF Receives: Other: bone filling materials |
| group 2 | Experimental | immediate implant placement and the buccal jumping gap was packed using xenograft Receives: Other: bone filling materials |
| group 3 | Experimental | immediate implant placement and the buccal jumping gap was packed using alloplast Receives: Other: bone filling materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal bone loss
Cone Beam CT (CBCT) was used measure marginal bone loss
Measured: 1 year
Secondary outcomes (2)
Implant Stability:
Resonance frequency analysis (RFA) was used to measure implant stability with an Osstell Mentor device.
Measured: 1 year
Peri-implant Pocket depth
A graduated probe was used to measure the distance between the base of the pocket and the gingival margin
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion1 Jan 2023
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 Immediate ImplantStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878392
- Sponsor's protocol ID
- A0103023OS
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elsheikh HA, Abdelsameaa SE, Elbahnasi AA, Abdel-Rahman FH. Comparison between platelet rich fibrin as space filling material versus xenograft and alloplastic bone grafting materials in immediate implant placement: a randomized clinical trial. BMC Oral Health. 2023 Dec 8;23(1):977. doi: 10.1186/s12903-023-03678-5.
PubMed 38066454
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Different Filling Materials in Immediate Implant
- ClinicalTrials.gov ID
- NCT05878392
- Acronym / sponsor ID
- A0103023OS
- Conditions
- Immediate Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 26 May 2023 (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.
36 patients, were included in this study. They were chosen from the Outpatient Clinic in the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable maxillary anterior and premolar teeth (esthetic zone) by immediate implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Other: bone filling materialsimmediate implant placement and the buccal jumping gap was packed using PRF |
| group 2 | Experimental | Other: bone filling materialsimmediate implant placement and the buccal jumping gap was packed using xenograft |
| group 3 | Experimental | Other: bone filling materialsimmediate implant placement and the buccal jumping gap was packed using alloplast |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient medically free from systemic diseases.
- Age above 18 years.
- A single maxillary anterior or premolar tooth that cannot be restored.
- No acute infection is present.
- Patients with sufficient quality and quantity of bone.
Key exclusion criteria (3 listed)
- A medical condition that would prevent implant surgery.
- Existence of non-treated generalized progressive periodontitis.
- Patients who are smokers.
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 |
|---|---|---|
| bone filling materialsthe buccal jumping gap was packed using PRF in group 1 the buccal jumping gap was packed using xenograft in group 2 the buccal jumping gap was packed using Alloplastic β-tricalcium phosphate in group 3 | Other | group 1, group 2, group 3 |
Primary outcome
marginal bone loss
Time frame: 1 year
Cone Beam CT (CBCT) was used measure marginal bone loss
2 secondary outcomes
Implant Stability:
Time frame: 1 year
Peri-implant Pocket depth
Time frame: 1 year
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 26 May 2023.
- Derived from this study: PubMed 38066454Elsheikh HA, Abdelsameaa SE, Elbahnasi AA, Abdel-Rahman FH. Comparison between platelet rich fibrin as space filling material versus xenograft and alloplastic bone grafting materials in immediate implant placement: a randomized clinical trial. BMC Oral Health. 2023 Dec 8;23(1):977. doi: 10.1186/s12903-023-03678-5.
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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 bone filling materials in people with Immediate Implant, run by Mansoura 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 6 inclusion and 3 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 26 May 2023. 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?
marginal bone loss (time frame: 1 year). 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 NCT05878392, 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 26 May 2023.