The mini-implants with angulated and non-angulated abutment
| ISRCTN | ISRCTN17902623 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17902623 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/10/2015
- Registration date
- 16/10/2015
- Last edited
- 28/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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)
Contact information
Scientific
Albaha University
Al-Baha
00966
Saudi Arabia
Public
Egypt
Cairo
0020
Egypt
Study information
| Study design | Randomized two-arm parallel design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effects of angulated and non angulated mini-implants abutment supporting mandibular overdenture on peri-implant bone height |
| Study objectives | The mini-implants with angulated abutment is better than non-angulated abutment |
| Ethics approval(s) | Dental Health Department at the Faculty of Applied Medical Sciences, Albaha University. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/2012 |
| Completion date | 12/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Male |
| Target number of participants | 30 patients responded to an advertisement campaign, but only 20 patients met the selection criteria |
| Key inclusion criteria | Patients with a lower flat ridge due to completely edentulous maxillary and mandibular ridges with resorbed ill-fitted lower dentures |
| Key exclusion criteria | Patients without a lower flat ridge due to completely edentulous maxillary and and mandibular ridges |
| Date of first enrolment | 01/10/2012 |
| Date of final enrolment | 01/06/2014 |
Locations
Countries of recruitment
- Egypt
- Saudi Arabia
Study participating centre
Faculty of Dentistry
Cairo
00966
Egypt
Sponsor information
University/education
Al-Baha
Al Baha province
00966
Saudi Arabia
"ROR" |
https://ror.org/0403jak37 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan |
Editorial Notes
28/06/2016: Scientific title changed from "The effects of mini-implants with angulated and non-angulated abutment on bone height"
