Complete EdentulismNCT03326453
Effect of Mini Implants Supported Over Dentures Versus Conventional Implant After Bone Expansion
A study testing Mini dental implant in people with Complete Edentulism, run by Cairo University.
Trial summary
The better form of ridge will provide using wider implants that can have better abilities to with stand forces and to prevent alveolar bone loss as much as possible. Ridge expansion gained some popularity due to easiness compared to any other procedure that can gain bone. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Mini dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 1 Jul 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous patients ranging from age 35 to 75 years
- Angle's Class I skeletal relationship
- Normal facial symmetry
- Cooperative patients
- Adequate inter-arch space not less than 12mm
Who cannot join
- Temporomandibular disorders
- Uncontrolled diabetes
- Bleeding disorders or anticoagulant therapy
- Flabby tissues or sharp mandibular residual ridge.
- Heavy smokers.
- Patient's with neuromuscular disorders
Show all 9Show fewer
- Patients on chemotherapy or radiotherapy
- Severe psychiatric disorders
- Angle's class II and III skeletal relationship
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Mini Implants Supported Over Dentures Versus Conventional Implant After Bone Expansion in Thin Mandibular Ridge on Patient Satisfaction:
The better form of ridge will provide using wider implants that can have better abilities to with stand forces and to prevent alveolar bone loss as much as possible. Ridge expansion gained some popularity due to easiness compared to any other procedure that can gain bone. However, this treatment modality needs to be evaluated as compared to Mini Dental Implants (MDIs) over denture in thin mandibular ridge.
In mandibular edentulous patients having thin ridge, does the mini implant supported over denture, compared to the conventional implant supported over denture after bone expansion affect bone height around implants?
Read the detailed description
PICO
P: Completely edentulous Patients.
I: Mandibular overdenture supported by mini dental implant.
C: Mandibular overdenture supported by conventional implant diameter after bone expansion.
O: outcomes as follows:
Primary Outcome: Patient satisfaction, Questionnaire Visual analog scale (VAS), Measuring unit: Mm. (Geckili et al.
Secondary Outcome: Bone height change, Measuring device: DIGORA® X ray, Measuring unit: Mm.
- Conditions
- Complete Edentulism
- Being tested
- Mini dental implant
- Keywords
- mini dental implant, overdenture, 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.
Mini dental implantDevice
Also called narrow dental implant
titanium mini dental implant which diameter less than 3 mm
| Study group | Role | What they receive |
|---|---|---|
| Mini Dental implant | Experimental | 2 mini dental implant of diameter 2.8 mm with length 10 mm will be inserted mandiblular ridge ≥5 mm mesial to the mental foraminato support overdentures for the intervention group. Receives: Device: Mini dental implant |
| conventional implant | No intervention | two slandered implant diameter 3.7 mm and length 10 mm will be placed in interforaminal region of mandiblular ridge support overdenture for the compartor group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients satisfaction
Visual analogue scale: a scale from 0-10 where 0 represents unsatisfied and 10 represents highly satisfied.
Measured: after six months of over denture insertion
Secondary outcomes (1)
Bone height change
measure the amount of bone height change in (millimetres) of all implant placed by DIGORA® X ray and Calliper device.
Measured: baseline (T0) initial bone height (millimetres), after six months usage of over denture(T1) bone height (millimetres), then after twelve-months usage of over denture(T2) bone height. 1st period (T1-T0) after 6 months 2nd period (T2-T1) after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Jul 2019 (estimated)
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 Complete EdentulismStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Ahmed Aboelfetooh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326453
- Sponsor's protocol ID
- CEBD-CU-2017-10-16
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Souza RF, Ribeiro AB, Della Vecchia MP, Costa L, Cunha TR, Reis AC, Albuquerque RF Jr. Mini vs. Standard Implants for Mandibular Overdentures: A Randomized Trial. J Dent Res. 2015 Oct;94(10):1376-84. doi: 10.1177/0022034515601959. Epub 2015 Aug 20.
PubMed 26294416
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mini Implants Supported Over Dentures Versus Conventional Implant After Bone Expansion in Thin Mandibular Ridge on Patient Satisfaction:
- ClinicalTrials.gov ID
- NCT03326453
- Acronym / sponsor ID
- CEBD-CU-2017-10-16
- Conditions
- Complete Edentulism
- Keywords
- mini dental implant, overdenture, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 31 Oct 2017 (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 better form of ridge will provide using wider implants that can have better abilities to with stand forces and to prevent alveolar bone loss as much as possible. Ridge expansion gained some popularity due to easiness compared to any other procedure that can gain bone. However, this treatment modality needs to be evaluated as compared to Mini Dental Implants (MDIs) over denture in thin mandibular ridge.
In mandibular edentulous patients having thin ridge, does the mini implant supported over denture, compared to the conventional implant supported over denture after bone expansion affect bone height around implants?
Detailed description
PICO
P: Completely edentulous Patients.
I: Mandibular overdenture supported by mini dental implant.
C: Mandibular overdenture supported by conventional implant diameter after bone expansion.
O: outcomes as follows:
Primary Outcome: Patient satisfaction, Questionnaire Visual analog scale (VAS), Measuring unit: Mm. (Geckili et al.
Secondary Outcome: Bone height change, Measuring device: DIGORA® X ray, Measuring unit: Mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini Dental implant | Experimental | Device: Mini dental implant2 mini dental implant of diameter 2.8 mm with length 10 mm will be inserted mandiblular ridge ≥5 mm mesial to the mental foraminato support overdentures for the intervention group. |
| conventional implant | No intervention | –two slandered implant diameter 3.7 mm and length 10 mm will be placed in interforaminal region of mandiblular ridge support overdenture for the compartor group. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completely edentulous patients ranging from age 35 to 75 years
- Angle's Class I skeletal relationship
- Normal facial symmetry
- Cooperative patients
- Adequate inter-arch space not less than 12mm
Key exclusion criteria (9 listed)
- Temporomandibular disorders
- Uncontrolled diabetes
- Bleeding disorders or anticoagulant therapy
- Flabby tissues or sharp mandibular residual ridge.
- Heavy smokers.
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 |
|---|---|---|
| Mini dental implantAlso: narrow dental implanttitanium mini dental implant which diameter less than 3 mm | Device | Mini Dental implant |
Primary outcome
patients satisfaction
Time frame: after six months of over denture insertion
Visual analogue scale: a scale from 0-10 where 0 represents unsatisfied and 10 represents highly satisfied.
1 secondary outcome
Bone height change
Time frame: baseline (T0) initial bone height (millimetres), after six months usage of over denture(T1) bone height (millimetres), then after twelve-months usage of over denture(T2) bone height. 1st period (T1-T0) after 6 months 2nd period (T2-T1) after 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Background: PubMed 26294416de Souza RF, Ribeiro AB, Della Vecchia MP, Costa L, Cunha TR, Reis AC, Albuquerque RF Jr. Mini vs. Standard Implants for Mandibular Overdentures: A Randomized Trial. J Dent Res. 2015 Oct;94(10):1376-84. doi: 10.1177/0022034515601959. Epub 2015 Aug 20.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Mini dental implant in people with Complete Edentulism, run by Cairo University.
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 9 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: status not confirmed, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osama Gaballa, MDS (0020127251106, osama.gaballa86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients satisfaction (time frame: after six months of over denture insertion). 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 NCT03326453, 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 31 Oct 2017.