Condition category
Oral Health
Date applied
09/10/2015
Date assigned
16/10/2015
Last edited
28/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Overdentures, also known as dental implants, are metal posts which are screwed directly into the jaw bone in order to support replacement teeth. Abutments are connectors that are placed on the top of a dental implant to connect the implant to the replacement tooth. Mini-implants have been successfully used to support complete dentures in edentulous patients (patients with no natural teeth) that have wasting (or resorption) of the bone holding the teeth (alveolar bone). The aim of this study is to see whether mini-implants with an angulated abutment (that is, an abutment placed at a different angle to the denture) is better than
a non-angulated abutment (that is, an abutment placed at the same angle than the denture).

Who can participate?
Patients who, having responded to an advertising campaign, have no natural teeth and have ill-fitting dentures due to resorption of the alveolar bone.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1
receive a non-angulated abutment. Those in group 2 receive angulated abutment. Alveloar bone height is measured 6 mnoths after treatment and again at 12, 18 and 24 months.

What are the possible benefits and risks of participating?
The use of mini-implants with non-angulated abutment may provide benefits for patients such as a stable, immediately functional aesthetic for overdentures for patients with wasting of the alveolar bone. There are no reported risks to taking part.

Where is the study run from?
Al-Azhar University, Faculty of Dentistry (Egypt)

When is the study starting and how long is it expected to run for?
October 2012 to December 2014

Who is funding the study?
Albaha University (Saudi Arabia)

Who is the main contact?
1. Professor Khalid Arafa (scientific)
2. Dr Hashim Ahmed (public)

Trial website

Contact information

Type

Scientific

Primary contact

Prof Khalid Arafa

ORCID ID

Contact details

Albaha University
Al-Baha
00966
Saudi Arabia

Type

Public

Additional contact

Dr Hashim Ahmed

ORCID ID

Contact details

Egypt
Cairo
0020
Egypt

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of angulated and non angulated mini-implants abutment supporting mandibular overdenture on peri-implant bone height

Acronym

Study hypothesis

The mini-implants with angulated abutment is better than non-angulated abutment

Ethics approval

Dental Health Department at the Faculty of Applied Medical Sciences, Albaha University.

Study design

Randomized two-arm parallel design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Mini-implants used to support complete dentures in edentulous patients with little bone width or length.

Intervention

One of the initial steps in non-angulated mini-implant insertion include the use of a surgical stent to the determined position of the abutment with four holes. Participants in this study were randomly allocated to one or two groups.

1. Group 1: received lower overdentures with non-angulated abutment. A non-angulated abutment means there is overstructure without any changes in angle of the abutment.
2. Group 2: received lower overdentures with angulated abutment, which means the angulated abutments were essential to redirect the screw holes in a communal pathway of attachment to help in the fabrication and fitting of the prosthesis. Furthermore, the abutments were utilized to redirect these holes in the lingual path. Lastly, in specific cases, it may not be possible to redirect and fabricate the screw with an angle of pre-fabricate 45° angulated abutments (selecting direction is easy with the octa 45° rotation angles).

Bones were evaluated for height after 6, 12, 18, and 24 months with panoramic x-ray. The mini-implants used were manufactured by Dentium, Slim Line, No: SDM1304.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Alveolar bone height, measured after 6 months with panoramic x-ray.

Secondary outcome measures

Alveolar bone height, measured after 12, 18, and 24 months with panoramic x-ray.

Overall trial start date

01/10/2012

Overall trial end date

12/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with a lower flat ridge due to completely edentulous maxillary and mandibular ridges with resorbed ill-fitted lower dentures

Participant type

Patient

Age group

Other

Gender

Male

Target number of participants

30 patients responded to an advertisement campaign, but only 20 patients met the selection criteria

Participant exclusion criteria

Patients without a lower flat ridge due to completely edentulous maxillary and and mandibular ridges

Recruitment start date

01/10/2012

Recruitment end date

01/06/2014

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

Al-Azhar University
Assiut Branch Faculty of Dentistry
Cairo
00966
Egypt

Sponsor information

Organisation

Albaha University

Sponsor details

Al-Baha
Al Baha province
00966
Saudi Arabia

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Albaha University (Saudi Arabia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

28/06/2016: Scientific title changed from "The effects of mini-implants with angulated and non-angulated abutment on bone height"