Bone LossNCT04928274
Bone Height Changes In Three Implants Retained Mandibular Overdenture
A study testing ball attachment to retain mandibular over denture, locator attachment to retain mandibular over denture and telescopic attachment to retain mandibular over denture in people with Bone Loss and Implant Site Reaction, run by Kafrelsheikh University at 3 sites in Egypt.
Trial summary
this study was to compare the bone height changes around three implant telescopic, locator, and ball retained mandibular overdentures. radiographic changes in peri-implant tissue in three groups were evaluated Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Bone Loss, Implant Site Reaction
- What is being tested?
- ball attachment to retain mandibular over denture, locator attachment to retain mandibular over denture and telescopic attachment to retain mandibular over denture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Jan 2020to 15 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ranging from 50 to 69 years old, patients should have no contra-indication for implant installation, all patients should perform a glycosylated hemoglobin analysis and only up to 8 were included in the study
Who cannot join
- Patients with any contraindications for implant placement or those who didn't comply with the follow ups were excluded from the study.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Cairo University
Cairo, 11511
Faculty of Dentistry , Kafrelshiekh university
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511
Faculty of Dentistry , Kafr El Shiekh University
Kafr ash Shaykh
About this study
Official title: Evaluation of Bone Height Changes In Three Implants Retained Mandibular Overdenture Using Three Different Attachment Design. A Randomized Clinical Trial.
this study was to compare the bone height changes around three implant telescopic, locator, and ball retained mandibular overdentures. radiographic changes in peri-implant tissue in three groups were evaluated
Read the detailed description
Twenty-four completely edentulous patients were recruited from the outpatient clinic of Removable Prosthodontics Cairo University. All patients recruited were seeking to install implants in their lower jaw, and have to meet the following inclusion criteria: age ranging from 50 to 69 years old, patients should have no contra-indication for implant installation, all patients should perform a glycosylated hemoglobin analysis and only up to 8 were included in the study. All patients had to sign an informed consent before the start of the study, and have to comply with the assigned follow-ups. Patients with any contraindications for implant placement or those who didn't comply with the follow ups were excluded from the study.
All patients included had maxillary and mandibular complete dentures fabricated following the conventional steps, after a period of 6 weeks adaptation, all patients were ready for implant installation. The lower denture was duplicated into a radiographic stent, having radio-opaque markers in the areas of implant installation. All patients had a CBCT x ray wearing the radiographic stent, to allow for proper implant planning and to visualize the height and width of the osteotomy site. The radiographic stent was then modified to a surgical stent by making a tunnel corresponding to the site of implant installation. All Patients in this study received three implants in the lower jaw at the premolar-canine area bilaterally and one implant in the midline at the central incisor area.
- Conditions
- Bone Loss, Implant Site Reaction
- Being tested
- ball attachment to retain mandibular over denture, locator attachment to retain mandibular over denture, telescopic attachment to retain mandibular over denture
- Keywords
- implant - over denture - bone height changes - attachment
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ball attachment to retain mandibular over dentureOther
each patient in group receive 3 locator attachment for over denture retention
locator attachment to retain mandibular over dentureOther
each patient in group receive 3 locator attachment for over denture retention
telescopic attachment to retain mandibular over dentureOther
each patient in group receive 3 telescopic attachment for over denture retention
| Study group | Role | What they receive |
|---|---|---|
| ball retained mandibular over denture | Other | each patient in this group received 3 implant installed in mandible and 3 ball attachments for retention of over denture Receives: Other: ball attachment to retain mandibular over denture |
| locator retained mandibular over denture | Other | Not described Receives: Other: locator attachment to retain mandibular over denture |
| telescopic retained mandibular over denture | Other | Not described Receives: Other: telescopic attachment to retain mandibular over denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone height measurement
The Digora software was then used to measure bone height changes on the mesial and distal surface of each implant. The Digora software was then used to measure bone height changes on the mesial and distal surface of each implant. The implant in the peri-apical x ray was calibrated by drawing a line from the junction of the implant and abutment to the apical end of the implant, this line was the calibration line corresponding to the implant real length which was 11.5mm. After the implant was calibrated, a line was drawn on each implant surface; at the mesial and distal surface starting from the first implant thread to bone contact to the apical implant thread to bone contact. The line drawn would correspond to the bone height on each surface . Two blinded operators have carried out the assessment of bone height changes in order to have accurate results.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Jan 2020
- Primary completion15 Mar 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Nourhan Ahmed Ragheb, Kafrelsheikh University
- Investigators
- Nouran Abdel Nabi, phd, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928274
- Sponsor's protocol ID
- KD/11/21
- Status last verified
- Aug 2021
- First submitted
- 4 Jun 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: study protocol
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
- Evaluation of Bone Height Changes In Three Implants Retained Mandibular Overdenture Using Three Different Attachment Design. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04928274
- Acronym / sponsor ID
- KD/11/21
- Conditions
- Bone Loss, Implant Site Reaction
- Keywords
- implant - over denture - bone height changes - attachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 16 Jun 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.
this study was to compare the bone height changes around three implant telescopic, locator, and ball retained mandibular overdentures. radiographic changes in peri-implant tissue in three groups were evaluated
Detailed description
Twenty-four completely edentulous patients were recruited from the outpatient clinic of Removable Prosthodontics Cairo University. All patients recruited were seeking to install implants in their lower jaw, and have to meet the following inclusion criteria: age ranging from 50 to 69 years old, patients should have no contra-indication for implant installation, all patients should perform a glycosylated hemoglobin analysis and only up to 8 were included in the study. All patients had to sign an informed consent before the start of the study, and have to comply with the assigned follow-ups. Patients with any contraindications for implant placement or those who didn't comply with the follow ups were excluded from the study.
All patients included had maxillary and mandibular complete dentures fabricated following the conventional steps, after a period of 6 weeks adaptation, all patients were ready for implant installation. The lower denture was duplicated into a radiographic stent, having radio-opaque markers in the areas of implant installation. All patients had a CBCT x ray wearing the radiographic stent, to allow for proper implant planning and to visualize the height and width of the osteotomy site. The radiographic stent was then modified to a surgical stent by making a tunnel corresponding to the site of implant installation. All Patients in this study received three implants in the lower jaw at the premolar-canine area bilaterally and one implant in the midline at the central incisor area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ball retained mandibular over denture | Other | Other: ball attachment to retain mandibular over dentureeach patient in this group received 3 implant installed in mandible and 3 ball attachments for retention of over denture |
| locator retained mandibular over denture | Other | Other: locator attachment to retain mandibular over denture |
| telescopic retained mandibular over denture | Other | Other: telescopic attachment to retain mandibular over denture |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age ranging from 50 to 69 years old, patients should have no contra-indication for implant installation, all patients should perform a glycosylated hemoglobin analysis and only up to 8 were included in the study
Key exclusion criteria (1 listed)
- Patients with any contraindications for implant placement or those who didn't comply with the follow ups were excluded from the study.
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 |
|---|---|---|
| ball attachment to retain mandibular over dentureeach patient in group receive 3 locator attachment for over denture retention | Other | ball retained mandibular over denture |
| locator attachment to retain mandibular over dentureeach patient in group receive 3 locator attachment for over denture retention | Other | locator retained mandibular over denture |
| telescopic attachment to retain mandibular over dentureeach patient in group receive 3 telescopic attachment for over denture retention | Other | telescopic retained mandibular over denture |
Primary outcome
Bone height measurement
Time frame: one year
The Digora software was then used to measure bone height changes on the mesial and distal surface of each implant. The Digora software was then used to measure bone height changes on the mesial and distal surface of each implant. The implant in the peri-apical x ray was calibrated by drawing a line from the junction of the implant and abutment to the apical end of the implant, this line was the calibration line corresponding to the implant real length which was 11.5mm. After the implant was calibrated, a line was drawn on each implant surface; at the mesial and distal surface starting from the first implant thread to bone contact to the apical implant thread to bone contact. The line drawn would correspond to the bone height on each surface . Two blinded operators have carried out the assessment of bone height changes in order to have accurate results.
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.
- Individual participant dataSharing planned: No. study protocol
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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.
Nouran Abdel Nabi, phd principal investigator
Cairo University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ball attachment to retain mandibular over denture, locator attachment to retain mandibular over denture and telescopic attachment to retain mandibular over denture in people with Bone Loss and Implant Site Reaction, run by Kafrelsheikh University at 3 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 1 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 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 3 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?
Bone height measurement (time frame: one year). 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.