Edentulous JawNCT04301115
Unilateral Attachment Versus Tooth Implant Supported Bridge
A study testing attachment, bridge and CONVENTIONAL in people with Edentulous Jaw, run by Cairo University at 1 site in Egypt.
Trial summary
Purpose: Evaluation of patients' satisfaction, biting force measurement and radiographic evaluation of abutment teeth of tooth implant supported bridge, unilateral attachment and conventional partial denture in mandibular distal extension cases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- attachment, bridge and CONVENTIONAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 1 Oct 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Unilateral mandibular distal extension area
- The abutments showed sufficient occluso-gingival height of its clinical crown
- Adequate inter-arch space and no tempro-mandibular joint disorders.
- No para-functional habits,
- Full opposing arch or restored with acceptable fixed restoration
- Minimal bone height11 mm at the lower second molar area.
Who cannot join
- Insufficent bone height in posterior area of mandible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attachment-retained Unilateral Partial Denture Versus Tooth Implant Supported Prosthesis in Mandibular Distal Extension Cases
Purpose: Evaluation of patients' satisfaction, biting force measurement and radiographic evaluation of abutment teeth of tooth implant supported bridge, unilateral attachment and conventional partial denture in mandibular distal extension cases.
Materials and methods: Twenty four patients were selected and divided into three equal groups, each of eight patients: patients of group I Patients received a fixed tooth implant supported bridge, patients of group II Patients received a removable unilateral attachment partial denture and group III Patients received a conventional removable partial denture.Evaluation included patient satisfaction and biting force measurement radiographic evaluation of terminal abutments.
Read the detailed description
Purpose: Evaluation of patients' satisfaction, biting force measurement and radiographic evaluation of abutment teeth of tooth implant supported bridge, unilateral attachment and conventional partial denture in mandibular distal extension cases.
Materials and methods: Twenty four patients were selected according to the following criteria: Patients with unilateral mandibular distal extension with last standing second premolar abutment, abutments showed sufficient occluso-gingival height and good periodontal condition. Patients were divided into three equal groups, each of eight patients: patients of group I Patients received a fixed tooth implant supported bridge, patients of group II Patients received a removable unilateral attachment partial denture and group III Patients received a conventional removable partial denture.Evaluation included patient satisfaction using "OHIP14" questionnaires and biting force measurement radiographic evaluation of terminal abutments.
- Conditions
- Edentulous Jaw
- Being tested
- attachment, bridge, CONVENTIONAL
- Keywords
- attachment,, patient satisfaction, radiographic evaluation, implant
- Medical subject headings
- Jaw, Edentulous, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attachmentOther
unilateral attachment from rehine 83
bridgeOther
tooth implant supported bridge
CONVENTIONALOther
Also called partial denture
conventional metalic partial denture
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Active comparator | conventional partial denture Receives: Other: CONVENTIONAL |
| attachment group | Experimental | unlateral attachment retained partial denture Receives: Other: attachment |
| tooth implant supporeted prosthesis | Experimental | tooth implant supported bridge Receives: Other: bridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
questionnaires
Measured: 1 month
Secondary outcomes (2)
biting force
measuring the biting force of the patients by sensor
Measured: 1 month
radiographic evaluation
evaluation of alveolar bone loss
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Feb 2018
- Primary completion20 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharaf Mohamed Yahia, Cairo University
- Investigators
- samira Ibrahim, prof, Principal investigator, professor of prosthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301115
- Sponsor's protocol ID
- 201802
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attachment-retained Unilateral Partial Denture Versus Tooth Implant Supported Prosthesis in Mandibular Distal Extension Cases
- ClinicalTrials.gov ID
- NCT04301115
- Acronym / sponsor ID
- 201802
- Conditions
- Edentulous Jaw
- Keywords
- attachment,, patient satisfaction, radiographic evaluation, implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 10 Mar 2020 (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.
Purpose: Evaluation of patients' satisfaction, biting force measurement and radiographic evaluation of abutment teeth of tooth implant supported bridge, unilateral attachment and conventional partial denture in mandibular distal extension cases.
Materials and methods: Twenty four patients were selected and divided into three equal groups, each of eight patients: patients of group I Patients received a fixed tooth implant supported bridge, patients of group II Patients received a removable unilateral attachment partial denture and group III Patients received a conventional removable partial denture.Evaluation included patient satisfaction and biting force measurement radiographic evaluation of terminal abutments.
Detailed description
Purpose: Evaluation of patients' satisfaction, biting force measurement and radiographic evaluation of abutment teeth of tooth implant supported bridge, unilateral attachment and conventional partial denture in mandibular distal extension cases.
Materials and methods: Twenty four patients were selected according to the following criteria: Patients with unilateral mandibular distal extension with last standing second premolar abutment, abutments showed sufficient occluso-gingival height and good periodontal condition. Patients were divided into three equal groups, each of eight patients: patients of group I Patients received a fixed tooth implant supported bridge, patients of group II Patients received a removable unilateral attachment partial denture and group III Patients received a conventional removable partial denture.Evaluation included patient satisfaction using "OHIP14" questionnaires and biting force measurement radiographic evaluation of terminal abutments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional group | Active comparator | Other: CONVENTIONALconventional partial denture |
| attachment group | Experimental | Other: attachmentunlateral attachment retained partial denture |
| tooth implant supporeted prosthesis | Experimental | Other: bridgetooth implant supported bridge |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral mandibular distal extension area
- The abutments showed sufficient occluso-gingival height of its clinical crown
- Adequate inter-arch space and no tempro-mandibular joint disorders.
- No para-functional habits,
- Full opposing arch or restored with acceptable fixed restoration
Key exclusion criteria (1 listed)
- Insufficent bone height in posterior area of mandible
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 |
|---|---|---|
| attachmentunilateral attachment from rehine 83 | Other | attachment group |
| bridgetooth implant supported bridge | Other | tooth implant supporeted prosthesis |
| CONVENTIONALAlso: partial dentureconventional metalic partial denture | Other | conventional group |
Primary outcome
patient satisfaction
Time frame: 1 month
questionnaires
2 secondary outcomes
biting force
Time frame: 1 month
radiographic evaluation
Time frame: 1 month
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 10 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Edentulous Jaw
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Recruiting
Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
Chewing Efficiency in Completely Edentulous Patients Rehabilitated With Implant-Supported Full-Arch Prostheses
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Jaw, Edentulous, Partially
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
Active, not recruiting
A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration
Jaw, Edentulous, Partially
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.
samira Ibrahim, prof principal investigator
professor of prosthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing attachment, bridge and CONVENTIONAL in people with Edentulous Jaw, run by Cairo 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 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 10 Mar 2020. 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 month). 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 10 Mar 2020.