Clinical trial NCT04582162: Comparison of Short Implant Assisted Mandibular Overdenture Designs
Official title: Comparison of Short Implant Assisted Mandibular Overdenture Designs (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Bone Resorption
Keywords: short implants
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-10-09
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to clinically and radiographically evaluate and compare the use of unsplinted and splinted short implants with ball abutments to support mandibular overdentures in cases with severe mandibular ridge resorption.

Detailed description: Twelve patients from the Prosthodontics Department in the Faculty of Dentistry, Alexandria University participated in the study. Patients were divided into 2 groups. The test group received 4 short implants with ball abutments for the construction of a mandibular assisted overdenture, while the control group received 4 short implants splinted using a bar with a ball attachment for retaining a mandibular overdenture.

Eligibility criteria: Inclusion Criteria:

* Completely edentulous patients.
* Mandibular ridge should be a maximum of 10mm height and with a minimum width of 8 mm to insert implants without grafting procedures.
* Patients free from systemic diseases that contradict the use of dental implants.
* Patients with class I ridge relation.
* Patients with adequate zone of keratinized mucosa.
* Patients with U-shaped or square shaped arches

Exclusion Criteria:

* Non-compliant patients based on history.
* Heavy smokers.
* Senile patients (over 75 years) with impaired neuromuscular control.

Primary outcomes:
measure: Implant stability
timeFrame: up to 12 months
measure: Peri-implant probing depth
timeFrame: up to 12 months
measure: Clinical attachment loss
timeFrame: up to 12 months
measure: Gingival inflammation (Modified gingival index)
timeFrame: up to 12 months
measure: Crestal bone loss
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Ahmed Weheda, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Ahmed A Abdelhakim, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Magued H Fahmy, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Nermeen A Rady, PhD
role: STUDY_CHAIR
References:
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citation: Stellingsma C, Meijer HJ, Raghoebar GM. Use of short endosseous implants and an overdenture in the extremely resorbed mandible: a five-year retrospective study. J Oral Maxillofac Surg. 2000 Apr;58(4):382-7; discussion 387-8. doi: 10.1016/s0278-2391(00)90917-0.