DentalbarNCT06401187
Patient Satisfaction and Maximum Biting Force in Co-Cr Bar Implant Overdenture
A study testing Bar overdenture in people with Dental, run by Minia University at 1 site in Egypt.
Trial summary
Statement of problem. Patient satisfaction and maximum biting force from patients who wear 2-implant-retained overdentures with different constructed bar attachments can be improved. Purpose. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Dental
- What is being tested?
- Bar overdenture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2022to 17 Jan 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with sufficient residual alveolar bone quantity and quality anterior to the mental foramen to receive self-taping root form titanium implants.
- Maxillary and Mandibular residual alveolar ridges covered with healthy mucosa without any remaining roots or local inflammation.
- Patients with sufficient inter-arch space (at least 15 mm) to have overdenture and bar attachment.
- U-shaped lower ridge to avoid the lingual placement of the bar that occurs with a V-shaped ridge.
- Patients with skeletal and dental class I.
Who cannot join
- Patients with systemic diseases such as cardiovascular diseases, any disease of immunity, febrile conditions such as epilepsy, metabolic disorders, osteoporosis, hyperparathyroidism, and impaired psychological conditions that might affect the oral tissues or the bone metabolic rate.
- Patients with local and general contraindications for surgical procedures.
- Patients with TMJ or neuromuscular disorder.
- Patients with Para functional habits such as bruxism and clenching.
- Patients with impacted teeth or remaining roots.
- Alcoholic patients.
Show all 10Show fewer
- Patients with a history of radiotherapy in the head and neck region.
- Non-cooperative patients.
- Patients with a history of bisphosphonate intake.
- Patients with flabby tissues, bony undercuts, sharp bony edges, thin ridges or abnormalities at the lower alveolar ridge and recent extraction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Patient Satisfaction and Maximum Biting Force of Three Different Constructed Bars in Implant Overdenture in One Year Follow-up
Statement of problem. Patient satisfaction and maximum biting force from patients who wear 2-implant-retained overdentures with different constructed bar attachments can be improved.
Purpose. This randomised controlled clinical trial assessed patient satisfaction and maximum biting force with three differently constructed bar-retained overdentures (conventional casting, Milling and 3D printing CAD/CAM techniques) within a one-year follow-up.
Material and methods. A total of 60 implants were placed in 30 mandibular jaws(30 participants). The jaws were randomly assigned to 1 of the 3 treatment groups: a 10 conventional technique cast Co-Cr bar attachment, a 10 Co-Cr CAD/CAM milled bar attachment, and a 10 Co-Cr CAD/CAM 3D-printed bar attachment all groups were connected to 2 implants in the canine area. Patient satisfaction was tested after 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and the Kruskal-Wallis test. Maximum biting force was tested at baseline,3 months, 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and ANOVA test.
Read the detailed description
A total of 60 implants were placed in 30 mandibular jaws(30 participants). The jaws were randomly assigned to 1 of the 3 treatment groups: a 10 conventional technique cast Co-Cr bar attachment, a 10 Co-Cr CAD/CAM milled bar attachment, and a 10 Co-Cr CAD/CAM 3D-printed bar attachment all groups were connected to 2 implants in the canine area. Patient satisfaction was tested after 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and the Kruskal-Wallis test. Maximum biting force was tested at baseline,3 months, 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and ANOVA test.
- Conditions
- Dental
- Being tested
- Bar overdenture
- Keywords
- implants,, Milled, 3D printed, Patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bar overdentureOther
Also called bar overdenture implants
use of bar attachments as retentive mean of denture
| Study group | Role | What they receive |
|---|---|---|
| Co-Cr conventional technique cast bar attachments | Active comparator | conventional technique cast bar attachments Receives: Other: Bar overdenture |
| Co-Cr CAD/CAM milled bar attachments | Experimental | Co-Cr CAD/CAM milled bar attachments Receives: Other: Bar overdenture |
| Co-Cr CAD/CAM 3D bar attachments | Experimental | Co-Cr CAD/CAM 3D bar attachments Receives: Other: Bar overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
questionnaire
Measured: 1 year
Secondary outcomes (1)
maximum biting force
occlusal force meter
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 posted6 May 2024
- Study start10 Nov 2022
- Primary completion15 Dec 2023
- Study completion17 Jan 2024
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 DentalStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mona nabawy, Minia University
- Investigators
- Amr E Badr, phd, Study chair, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401187
- Sponsor's protocol ID
- 644
- Other IDs
- Amr Esmail, shaimaa Radwan
- Acronym
- bar
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This randomised controlled clinical trial assessed patient satisfaction and maximum biting force with three differently constructed bar-retained overdentures (conventional casting, Milling and 3D printing CAD/CAM techniques) within a one-year follow-up.
Publications
Badr AMI, Nabawy M, Mohammed GF, Radwan SA. Evaluation of patient satisfaction and maximum biting force of three differently constructed bars on two implants retaining mandibular overdenture - one year follow-up (a randomized controlled clinical trial). BMC Oral Health. 2024 Nov 9;24(1):1360. doi: 10.1186/s12903-024-05092-x.
PubMed 39522003
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Satisfaction and Maximum Biting Force of Three Different Constructed Bars in Implant Overdenture in One Year Follow-up
- ClinicalTrials.gov ID
- NCT06401187
- Acronym / sponsor ID
- bar / 644
- Conditions
- Dental
- Keywords
- implants,, Milled, 3D printed, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 6 May 2024 (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.
Statement of problem. Patient satisfaction and maximum biting force from patients who wear 2-implant-retained overdentures with different constructed bar attachments can be improved.
Purpose. This randomised controlled clinical trial assessed patient satisfaction and maximum biting force with three differently constructed bar-retained overdentures (conventional casting, Milling and 3D printing CAD/CAM techniques) within a one-year follow-up.
Material and methods. A total of 60 implants were placed in 30 mandibular jaws(30 participants). The jaws were randomly assigned to 1 of the 3 treatment groups: a 10 conventional technique cast Co-Cr bar attachment, a 10 Co-Cr CAD/CAM milled bar attachment, and a 10 Co-Cr CAD/CAM 3D-printed bar attachment all groups were connected to 2 implants in the canine area. Patient satisfaction was tested after 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and the Kruskal-Wallis test. Maximum biting force was tested at baseline,3 months, 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and ANOVA test.
Detailed description
A total of 60 implants were placed in 30 mandibular jaws(30 participants). The jaws were randomly assigned to 1 of the 3 treatment groups: a 10 conventional technique cast Co-Cr bar attachment, a 10 Co-Cr CAD/CAM milled bar attachment, and a 10 Co-Cr CAD/CAM 3D-printed bar attachment all groups were connected to 2 implants in the canine area. Patient satisfaction was tested after 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and the Kruskal-Wallis test. Maximum biting force was tested at baseline,3 months, 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and ANOVA test.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Co-Cr conventional technique cast bar attachments | Active comparator | Other: Bar overdentureconventional technique cast bar attachments |
| Co-Cr CAD/CAM milled bar attachments | Experimental | Other: Bar overdentureCo-Cr CAD/CAM milled bar attachments |
| Co-Cr CAD/CAM 3D bar attachments | Experimental | Other: Bar overdentureCo-Cr CAD/CAM 3D bar attachments |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with sufficient residual alveolar bone quantity and quality anterior to the mental foramen to receive self-taping root form titanium implants.
- Maxillary and Mandibular residual alveolar ridges covered with healthy mucosa without any remaining roots or local inflammation.
- Patients with sufficient inter-arch space (at least 15 mm) to have overdenture and bar attachment.
- U-shaped lower ridge to avoid the lingual placement of the bar that occurs with a V-shaped ridge.
- Patients with skeletal and dental class I.
Key exclusion criteria (10 listed)
- Patients with systemic diseases such as cardiovascular diseases, any disease of immunity, febrile conditions such as epilepsy, metabolic disorders, osteoporosis, hyperparathyroidism, and impaired psychological conditions that might affect the oral tissues or the bone metabolic rate.
- Patients with local and general contraindications for surgical procedures.
- Patients with TMJ or neuromuscular disorder.
- Patients with Para functional habits such as bruxism and clenching.
- Patients with impacted teeth or remaining roots.
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 |
|---|---|---|
| Bar overdentureAlso: bar overdenture implantsuse of bar attachments as retentive mean of denture | Other | Co-Cr CAD/CAM 3D bar attachments, Co-Cr CAD/CAM milled bar attachments, Co-Cr conventional technique cast bar attachments |
Primary outcome
Patient Satisfaction
Time frame: 1 year
questionnaire
1 secondary outcome
maximum biting force
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 16 May 2024.
- Derived from this study: PubMed 39522003Badr AMI, Nabawy M, Mohammed GF, Radwan SA. Evaluation of patient satisfaction and maximum biting force of three differently constructed bars on two implants retaining mandibular overdenture - one year follow-up (a randomized controlled clinical trial). BMC Oral Health. 2024 Nov 9;24(1):1360. doi: 10.1186/s12903-024-05092-x.
- Individual participant dataSharing planned: No. This randomised controlled clinical trial assessed patient satisfaction and maximum biting force with three differently constructed bar-retained overdentures (conventional casting, Milling and 3D printing CAD/CAM techniques) within a one-year follow-up.
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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.
Amr E Badr, phd study chair
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bar overdenture in people with Dental, run by Minia 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 5 inclusion and 10 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 16 May 2024. 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?
Patient Satisfaction (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 NCT06401187, 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 16 May 2024.