Implant Site ReactionNCT06151314
Bone Density and Marginal Bone Height Changes Around Dental Implants
A study testing Dental implants. in people with Implant Site Reaction, run by National Research Centre, Egypt at 2 sites in Egypt.
Trial summary
The increased benefits to the edentulous population from implant supported overdenture is overwhelming in terms of better quality of life, emotional stability, improved function, enhanced esthetics and clinical comfort.1-6 Implant supported prosthesis is considered a viable option for partially edentulous patients7. Read more about this study
- Who is it for?
- Ages 40 to 50 years, women only
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- Dental implants.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Dec 2022to 5 Dec 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 40 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- non smokers
- Patients having long anterior mandibular edentulous span.
- Highly cooperative and motivated patients.
- Patients Systemically free from any immunosuppressive diseases.
- Patients free from Diabetes, Hypertension, Cancer, any mental or physical diseases.
- Patients not receiving any Radiotherapy or chemotherapy treatment.
Who cannot join
- -Mandibular arch with thin knife edge, flat or flabby ridge, recent extractions, and foreign bodies.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Bone Density and Marginal Bone Height Changes Around Dental Implants Supporting and Retaining Different Types of Prostheses of Mandibular Kennedy Class VI
The increased benefits to the edentulous population from implant supported overdenture is overwhelming in terms of better quality of life, emotional stability, improved function, enhanced esthetics and clinical comfort.1-6 Implant supported prosthesis is considered a viable option for partially edentulous patients7. The oral rehabilitation of a long anterior mandibular edentulous span with a fixed or removable implant-supported prosthesis using appropriate prostheses have been a target in oral implant research for the last year. The longevity of any implant prosthesis depends on successful osseointegration and implant stability. Cone beam computed tomography (CBCT ) has also been used extensively for the follow-up of dental implants and is considered one of the tools for assessing implant success
Read the detailed description
This study will be conducted on 6 patients having mandibula Kennedy Class VI (anterior edentulous span) Each patient will receive 5 dental implants in the interforaminal area. The patients will be randomly categorized into two groups. According to the final restoration they will receive.
Group I: will receive a digital milled implant supported overdenture. While Group II will receive implant supported fixed bridge.
The marginal bone height changes and bone density around the dental implants will be evaluated at the time of prosthesis insertion, after one and three month.
Research Procedures:
- Patient selection: will be following inclusion and exclusion criteria.
- 5 implants will be installed in the interforaminal area for each patient.
- Digital impression, bite registration, try in and delivery of the final prosthesis for each group will follow the conventional methods.
- The marginal bone height changes and bone density around the dental implants using CBCT will be evaluated at the time of prosthesis insertion, after one and three month.
- Statistical analysis: Data will be collected, tabulated, and statistically analyzed using Microsoft Excel ® 2016, Statistical Package for Social Science (SPSS)® Ver. 24. and Minitab ® statistical software Ver. 16.
- Conditions
- Implant Site Reaction
- Being tested
- Dental implants.
- Keywords
- digital milled partial overdenture, Bone density, Fixed bridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implants.Procedure or surgery
Also called OXY implants
5 conventional implants measuring from 4 to 5 mm in width and 7 to 10mm in length according to the bone width were inserted in the mandible from right premolar area to left premolar area
| Study group | Role | What they receive |
|---|---|---|
| "digital milled implant supported removable partial overdenture | Active comparator | patients received digital milled implant supported removable partial overdenture. Receives: Procedure: Dental implants. |
| "implant supported fixed bridge" | Active comparator | patients received an implant supported fixed bridge Receives: Procedure: Dental implants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of change of bone density around dental implants
bone density was assessed by cone beam computed tomography
Measured: on the first day,on 1 month ,3months
Secondary outcomes (1)
assessment of change of bone height around dental implants
bone height was assessed by cone beam computed tomography
Measured: on the first day,on 1 month ,3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Dec 2022
- Primary completion1 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menatallah Mohamed Elhotieby, National Research Centre, Egypt
- Investigators
- Menatallah M. Elhotieby, Researcher, Principal investigator, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151314
- Sponsor's protocol ID
- National Research Centre
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2023
- Last updated
- 21 Dec 2023
- 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 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Density and Marginal Bone Height Changes Around Dental Implants Supporting and Retaining Different Types of Prostheses of Mandibular Kennedy Class VI
- ClinicalTrials.gov ID
- NCT06151314
- Acronym / sponsor ID
- National Research Centre
- Conditions
- Implant Site Reaction
- Keywords
- digital milled partial overdenture, Bone density, Fixed bridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 30 Nov 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.
The increased benefits to the edentulous population from implant supported overdenture is overwhelming in terms of better quality of life, emotional stability, improved function, enhanced esthetics and clinical comfort.1-6 Implant supported prosthesis is considered a viable option for partially edentulous patients7. The oral rehabilitation of a long anterior mandibular edentulous span with a fixed or removable implant-supported prosthesis using appropriate prostheses have been a target in oral implant research for the last year. The longevity of any implant prosthesis depends on successful osseointegration and implant stability. Cone beam computed tomography (CBCT ) has also been used extensively for the follow-up of dental implants and is considered one of the tools for assessing implant success
Detailed description
This study will be conducted on 6 patients having mandibula Kennedy Class VI (anterior edentulous span) Each patient will receive 5 dental implants in the interforaminal area. The patients will be randomly categorized into two groups. According to the final restoration they will receive.
Group I: will receive a digital milled implant supported overdenture. While Group II will receive implant supported fixed bridge.
The marginal bone height changes and bone density around the dental implants will be evaluated at the time of prosthesis insertion, after one and three month.
Research Procedures:
- Patient selection: will be following inclusion and exclusion criteria.
- 5 implants will be installed in the interforaminal area for each patient.
- Digital impression, bite registration, try in and delivery of the final prosthesis for each group will follow the conventional methods.
- The marginal bone height changes and bone density around the dental implants using CBCT will be evaluated at the time of prosthesis insertion, after one and three month.
- Statistical analysis: Data will be collected, tabulated, and statistically analyzed using Microsoft Excel ® 2016, Statistical Package for Social Science (SPSS)® Ver. 24. and Minitab ® statistical software Ver. 16.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "digital milled implant supported removable partial overdenture | Active comparator | Procedure: Dental implants.patients received digital milled implant supported removable partial overdenture. |
| "implant supported fixed bridge" | Active comparator | Procedure: Dental implants.patients received an implant supported fixed bridge |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- non smokers
- Patients having long anterior mandibular edentulous span.
- Highly cooperative and motivated patients.
- Patients Systemically free from any immunosuppressive diseases.
- Patients free from Diabetes, Hypertension, Cancer, any mental or physical diseases.
Key exclusion criteria (1 listed)
- -Mandibular arch with thin knife edge, flat or flabby ridge, recent extractions, and foreign bodies.
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 |
|---|---|---|
| Dental implants.Also: OXY implants5 conventional implants measuring from 4 to 5 mm in width and 7 to 10mm in length according to the bone width were inserted in the mandible from right premolar area to left premolar area | Procedure or surgery | "digital milled implant supported removable partial overdenture, "implant supported fixed bridge" |
Primary outcome
assessment of change of bone density around dental implants
Time frame: on the first day,on 1 month ,3months
bone density was assessed by cone beam computed tomography
1 secondary outcome
assessment of change of bone height around dental implants
Time frame: on the first day,on 1 month ,3months
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 21 Dec 2023.
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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.
Menatallah M. Elhotieby, Researcher principal investigator
National Research Centre, Egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implants. in people with Implant Site Reaction, run by National Research Centre, Egypt at 2 sites 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 1 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 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
assessment of change of bone density around dental implants (time frame: on the first day,on 1 month ,3months). 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 21 Dec 2023.