Comparison of Short Implant Assisted Mandibular Overdenture Designs

NCT ID: NCT04582162

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mandibular Bone Resorption

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

short implants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Unsplinted implants

Group Type EXPERIMENTAL

Unsplinted implants

Intervention Type OTHER

Patients received ball abutments on each implant without splinting for retaining an implant retained mandibular overdenture.

Splinted implants

Group Type ACTIVE_COMPARATOR

Splinted implants

Intervention Type OTHER

Patients had their implants splinted using Rhein bars with ball extension for retaining an implant retained mandibular overdenture.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Unsplinted implants

Patients received ball abutments on each implant without splinting for retaining an implant retained mandibular overdenture.

Intervention Type OTHER

Splinted implants

Patients had their implants splinted using Rhein bars with ball extension for retaining an implant retained mandibular overdenture.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alexandria University

OTHER

Sponsor Role collaborator

Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nourhan M.Aly

Assistant Lecturer of Dental Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed Weheda, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Egypt

Ahmed A Abdelhakim, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Magued H Fahmy, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Nermeen A Rady, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

Rocchietta I, Fontana F, Simion M. Clinical outcomes of vertical bone augmentation to enable dental implant placement: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):203-15. doi: 10.1111/j.1600-051X.2008.01271.x.

Reference Type BACKGROUND
PMID: 18724851 (View on PubMed)

Bell RB, Blakey GH, White RP, Hillebrand DG, Molina A. Staged reconstruction of the severely atrophic mandible with autogenous bone graft and endosteal implants. J Oral Maxillofac Surg. 2002 Oct;60(10):1135-41. doi: 10.1053/joms.2002.34986.

Reference Type BACKGROUND
PMID: 12378486 (View on PubMed)

Gentile MA, Chuang SK, Dodson TB. Survival estimates and risk factors for failure with 6 x 5.7-mm implants. Int J Oral Maxillofac Implants. 2005 Nov-Dec;20(6):930-7.

Reference Type BACKGROUND
PMID: 16392351 (View on PubMed)

Annibali S, Cristalli MP, Dell'Aquila D, Bignozzi I, La Monaca G, Pilloni A. Short dental implants: a systematic review. J Dent Res. 2012 Jan;91(1):25-32. doi: 10.1177/0022034511425675. Epub 2011 Oct 27.

Reference Type BACKGROUND
PMID: 22034499 (View on PubMed)

Baggi L, Cappelloni I, Di Girolamo M, Maceri F, Vairo G. The influence of implant diameter and length on stress distribution of osseointegrated implants related to crestal bone geometry: a three-dimensional finite element analysis. J Prosthet Dent. 2008 Dec;100(6):422-31. doi: 10.1016/S0022-3913(08)60259-0.

Reference Type BACKGROUND
PMID: 19033026 (View on PubMed)

Bernard JP, Szmukler-Moncler S, Pessotto S, Vazquez L, Belser UC. The anchorage of Branemark and ITI implants of different lengths. I. An experimental study in the canine mandible. Clin Oral Implants Res. 2003 Oct;14(5):593-600. doi: 10.1034/j.1600-0501.2003.120908.x.

Reference Type BACKGROUND
PMID: 12969363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10759117 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

short implant in overdentures

Identifier Type: -

Identifier Source: org_study_id