Quality of LifeNCT02861313
Oral Health Related Quality of Life and Peri-implant Condition in Single Implant Overdenture
A study testing CM LOC attachment and ball attachment in people with Quality of Life and Implant, run by Cairo University at 1 site in Egypt.
Trial summary
Comparing the quality of life and periimplant condition around a single implant retained mandibular overdenture in two groups one will have a ball attachment and the other is having a (CM-LOC) one. Read more about this study
- Who is it for?
- Ages 50 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Implant
- What is being tested?
- CM LOC attachment and ball attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Apr 2018
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No contraindications for implantation.
- Each patient has to perform both a random blood sugar and Glycosylated Hemoglobin analysis. Patients with a Glycosylated hemoglobin test HbA1c up to 8% and a normal blood sugar level (79 to 110) or controlled diabetic patients (90-130 fasting according to American Association of Diabetes) will be included.
- Sufficient bone width (≥ 6 mm) in the anterior region to place an implant. It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
- Residual bone height ranging from 11-20 mm with the lowest vertical height in the midline of the mandible not less than 13 mm This will be confirmed by the CBCT.
- Patients seeking to install a single symphyseal implant and for whom new dentures will be constructed.
- Patients, who are dissatisfied with the retention and stability of their technically satisfactory dentures.
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- Patients, who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, it is found that there are technical problems with regard to denture design and/or occlusion; then new maxillary and mandibular dentures will be fabricated
- All patients should have adapted to their dentures for at least six weeks before being included in the trial.
- Patients providing written informed consents to participate in the trial and this will be done before the scheduled date for implant installation.
Who cannot join
- Patients with a systemic or local contra-indication for implant placement.
- Satisfied patients with the retention of their mandibular denture as well as unsatisfied patients with their maxillary denture.
- Patient with a mandibular denture height less than 6 mm between the base of the denture and the incisal edge of the central incisors (as measured by a caliper) or with 12 mm crown height space as measured by a ruler from the incisal edge till the crest of the ridge. This will be done from a putty index of the diagnostic set up.
- Incompliant and not cooperative patients.
- Patients smoking more than 10 cigarettes per day.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Removable Prosthodontic Department, Faculty of Oral and Dental Medicine - Cairo University
Cairo, +02
About this study
Official title: Oral Health Related Quality of Life and Peri-implant Condition in Single Implant Mandibular Overdenture Retained by CM LOC Versus Ball Attachment: A Randomized Controlled Trial
Comparing the quality of life and periimplant condition around a single implant retained mandibular overdenture in two groups one will have a ball attachment and the other is having a (CM-LOC) one.
Read the detailed description
Single implant retained mandibular overdenture is considered an economic and simple treatment modality for edentulous subjects. Resin matrix (CM LOC) is one of the low profile attachments which represent a promising retention values with subsequent improvement in chewing ability and in turns enhance patient quality of life.Oral health impact profile for edentulous patient (OHIP-EDENT) is more specific to edentulous subjects.
Peri-implant soft tissue health (bleeding, inflammation, etc...) is a valuable marker to implant success. The study will record different attachment influenced-tissue response and its relation to implant success and oral health related quality of life (OHRQOL)
- Conditions
- Quality of Life, Implant
- Being tested
- CM LOC attachment, ball attachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM LOC attachmentDevice
Also called resin matrix attachment
CM LOC attachment
ball attachmentDevice
Also called metallic ball attachment
Ball attachment
| Study group | Role | What they receive |
|---|---|---|
| CM LOC attachment | Experimental | CM LOC attachment other names: resin matrix attachment Receives: Device: CM LOC attachment |
| ball attachment | Active comparator | ball attachment other names metallic ball attachment Receives: Device: ball attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in oral health related quality of life using (oral health impact profile edentulous) questionnaire (OHIP-EDENT)
likert scale from 0-4
Measured: from baseline up to 5 years
Secondary outcomes (3)
change in modified gingival index
score measurement from 0-4 where 0 is no inflammation and 4 is sever inflammation
Measured: from baseline up to 5 years
change in plaque index
score measurement from 0-3 where 0 denotes absence of plaque, 3 abundant plaque
Measured: from baseline up to 5 years
modified bleeding index
score measurement from 0-3 where 0 denotes no bleeding, 3 profuse bleeding
Measured: from baseline up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Abdelaal Mohammed, Cairo University
- Investigators
- marwa AA mohammed, A lecturer, Principal investigator, non affliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861313
- Sponsor's protocol ID
- CEBD-CU-2016-07-175
- Status last verified
- Sep 2019
- First submitted
- 29 Jul 2016
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Related Quality of Life and Peri-implant Condition in Single Implant Mandibular Overdenture Retained by CM LOC Versus Ball Attachment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02861313
- Acronym / sponsor ID
- CEBD-CU-2016-07-175
- Conditions
- Quality of Life, Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 10 Aug 2016 (estimated)
- 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.
Comparing the quality of life and periimplant condition around a single implant retained mandibular overdenture in two groups one will have a ball attachment and the other is having a (CM-LOC) one.
Detailed description
Single implant retained mandibular overdenture is considered an economic and simple treatment modality for edentulous subjects. Resin matrix (CM LOC) is one of the low profile attachments which represent a promising retention values with subsequent improvement in chewing ability and in turns enhance patient quality of life.Oral health impact profile for edentulous patient (OHIP-EDENT) is more specific to edentulous subjects.
Peri-implant soft tissue health (bleeding, inflammation, etc...) is a valuable marker to implant success. The study will record different attachment influenced-tissue response and its relation to implant success and oral health related quality of life (OHRQOL)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM LOC attachment | Experimental | Device: CM LOC attachmentCM LOC attachment other names: resin matrix attachment |
| ball attachment | Active comparator | Device: ball attachmentball attachment other names metallic ball attachment |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- No contraindications for implantation.
- Each patient has to perform both a random blood sugar and Glycosylated Hemoglobin analysis. Patients with a Glycosylated hemoglobin test HbA1c up to 8% and a normal blood sugar level (79 to 110) or controlled diabetic patients (90-130 fasting according to American Association of Diabetes) will be included.
- Sufficient bone width (≥ 6 mm) in the anterior region to place an implant. It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
- Residual bone height ranging from 11-20 mm with the lowest vertical height in the midline of the mandible not less than 13 mm This will be confirmed by the CBCT.
- Patients seeking to install a single symphyseal implant and for whom new dentures will be constructed.
Key exclusion criteria (5 listed)
- Patients with a systemic or local contra-indication for implant placement.
- Satisfied patients with the retention of their mandibular denture as well as unsatisfied patients with their maxillary denture.
- Patient with a mandibular denture height less than 6 mm between the base of the denture and the incisal edge of the central incisors (as measured by a caliper) or with 12 mm crown height space as measured by a ruler from the incisal edge till the crest of the ridge. This will be done from a putty index of the diagnostic set up.
- Incompliant and not cooperative patients.
- Patients smoking more than 10 cigarettes per day.
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 |
|---|---|---|
| CM LOC attachmentAlso: resin matrix attachmentCM LOC attachment | Device | CM LOC attachment |
| ball attachmentAlso: metallic ball attachmentBall attachment | Device | ball attachment |
Primary outcome
change in oral health related quality of life using (oral health impact profile edentulous) questionnaire (OHIP-EDENT)
Time frame: from baseline up to 5 years
likert scale from 0-4
3 secondary outcomes
change in modified gingival index
Time frame: from baseline up to 5 years
change in plaque index
Time frame: from baseline up to 5 years
modified bleeding index
Time frame: from baseline up to 5 years
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 4 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
marwa AA mohammed, A lecturer principal investigator
non affliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CM LOC attachment and ball attachment in people with Quality of Life and Implant, 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 9 inclusion and 5 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 4 Sep 2019. 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?
change in oral health related quality of life using (oral health impact profile edentulous) questionnaire (OHIP-EDENT) (time frame: from baseline up to 5 years). 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 4 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.