ClinicalTrials.gg
Status unknownNCT03326453Updated Oct 31, 2017

Effect of Mini Implants Supported Over Dentures Versus Conventional Implant After Bone Expansion

An interventional study of Mini dental implant in Complete Edentulism, sponsored by Cairo University. Status unknown. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-31.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 34 studies in Patient Satisfaction by Cairo University — 2 open to participants now, 2 under way, none of them phase 3. Patient Satisfaction · Cairo University.

Planned enrollment
10th of 32
36 · median 25
Started
2017
with 5 others
No phase
29 of 34
2 open now
Registered
7th of 34
by date

Among the 34 studies in Patient Satisfaction by Cairo University, this one is the 10th largest by planned enrollment of the 32 interventional ones that give a count, is one of 6 that started in 2017, is one of 29 with no phase, and was the 7th registered.

Patient Satisfaction

877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.

Browse Patient Satisfaction studies →

Open to participants now

2 of the 34 studies in Patient Satisfaction by Cairo University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 99 Patient Satisfaction studies recruiting now, 61 (62%) set no upper age limit and 30 (30%) stop at 75 or younger; 14 take children under 18; 26 take healthy volunteers.

This study: 45 Years to 80 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 34 studies in Patient Satisfaction by Cairo University, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Complete Edentulism

Browse trials for

Keywords

  • mini dental implant
  • overdenture
  • Patient satisfaction
04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Temporomandibular disorders
  • Uncontrolled diabetes
  • Bleeding disorders or anticoagulant therapy
  • Flabby tissues or sharp mandibular residual ridge.
  • Heavy smokers.
  • Patient's with neuromuscular disorders
  • Patients on chemotherapy or radiotherapy
  • Severe psychiatric disorders
  • Angle's class II and III skeletal relationship
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Mini Dental implant

    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.

    Device: Mini dental implant

  • No intervention
    conventional implant

    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.

Interventions

  • DeviceMini dental implant

    titanium mini dental implant which diameter less than 3 mm

    Also known as: narrow dental implant

06

What researchers measure

Primary outcomes

  1. patients satisfaction

    Visual analogue scale: a scale from 0-10 where 0 represents unsatisfied and 10 represents highly satisfied.

    Time frame: 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.

    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

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2017; primary completion for Dec 2018, 13 months later.

Of 368 non-industry interventional studies with no phase under Patient Satisfaction, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 13 months is close to that.

Counting every sponsor, half of 370 studies reached it within 12 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2017
First posted
Oct 31, 2017
StartEst.
Nov 1, 2017
Primary completionEst.
Dec 1, 2018
CompletionEst.
Jul 1, 2019
Last update
Oct 31, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03326453
Lead sponsor
Cairo University
Responsible party
Osama Ahmed Aboelfetooh (Principle investigator, Cairo University) — Principal investigator
First posted
Oct 31, 2017
Start date
Nov 1, 2017 (estimated)
Primary completion
Dec 1, 2018 (estimated)
Completion
Jul 1, 2019 (estimated)
Last update
Oct 31, 2017

Study contacts

Osama Gaballa, MDS
Contact
osama.gaballa86@gmail.com
0020127251106

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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