Plain English Summary
Background and study aims
Overdentures are dentures that are supported by the natural teeth on either side of them. These surrounding teeth are referred to as abutment teeth. Unlike conventional dentures, overdentures cannot be removed from the mouth by the patient. Root canal treatment is a dental procedure to treat an infection in the centre (root canal system) of a tooth. Also referred to as endodontics, the treatment involves removing the infected soft tissue of the tooth (the pulp) and filling the root canal with a dental filling. As the pulp of the tooth has been removed and there is no longer a blood supply to the tooth, the tooth is considered dead, or non-vital. Non-vital teeth can be more fragile and more likely to break than vital (live) teeth. This study looks at the effect of overdentures over vital and non-vital abutment teeth on teeth stability.
Who can participate?
Men aged at least 59 years and in need of overdentures.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given overdentures supported by vital abutment teeth. Those in group 2 are given overdentures supported by non-vital abutment teeth. Attachment loss and teeth mobility are then assessed after 3 months, 6 months and 12 months after treatment.
What are the possible benefits and risks of participating?
The study has many benefits for patients including being less expensive and invasive and increasing the level of satisfaction and quality of life.
Where is the study run from?
The Dental Clinic, Faculty of Dentistry at Al-Azhar University-Assiut Branch in Egypt
When is the study starting and how long is it expected to run for?
December 2013 to February 2015
Who is funding the study?
Albaha University (Saudi Arabia)
Who is the main contact?
1. Professor Khalid Arafa (public)
2. Dr Waled Ahmed (scientific)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Khalid Afra
ORCID ID
http://orcid.org/0000-0002-3597-5073
Contact details
Al-Baha
KSA
Al-Baha
00966
Saudi Arabia
Type
Public
Additional contact
Dr Waled Ahmed
ORCID ID
Contact details
Albaha University
Al-Baha
00966
Saudi Arabia
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of overdenture with vital and non-vital abutment teeth on tooth stability
Acronym
Study hypothesis
The use of overdenture with vital abutment teeth is better than non-vital abutment teeth.
Ethics approval
Dental Health Department of the Faculty of Applied Medical Sciences, Albaha University, 01/12/2013
Study design
A randomized experimental-parallel design
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Implant overdentures
Intervention
The patients were randomly divided into two groups each of 15 patients, both treated with overdenture, but they were different in the abutment teeth, the first group received vital abutment teeth while the second group received non-vital (endodontically treated) teeth. Both groups used overdentures (after finishing the overdenture in dental lab, the patients taking the construction) and then evaluated 3, then 6 and lastly after 12 months, as regarding to the attachment loss and tooth mobility of the abutment teeth in a both groups with vital and non-vital abutment teeth.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Attachment loss:
The attachment loss was measured according to Romfjord (1967), the measurement of attachment loss from the gingival margin till the cementoenamel junction. The clinical attachment loss (CAL) is the measurement of the loss of the position of the soft tissue in relation to the cemento-enamel junction (CEJ) that is a fixed point that does not change throughout life. The CAL is assessed by both the probing depth plus the gingival margin level. For instance, if the probing depth measurement 4 mm and gingival margin level 2 mm, the clinical attachment loss will be 6 mm.
Measured at 3 months, 6 months and 12 months after treatment.
Secondary outcome measures
Tooth mobility:
The measurement of tooth mobility was done according to Everett and Sten (1969) the measurement of tooth mobility baccolingual by two dental instruments (probe or mirror) and classified as first degree mobility 0 mm, second degree mobility 1 mm and third degree mobility more than 1 mm. The tooth mobility was assessed by using the ends of two dental instruments handles (probe or mirrors). The mobility was graded into class I, II, and III. Four implants were placed to attach a fixed bar, three clips were placed in the overdenture for retention. The overdentures root-supported have been fabricated to accurate periodontal and/or occlusal collapse. Some teeth are corrected to support and/or keep the prosthesis.
Measured at 3 months, 6 months and 12 months after treatment.
Overall trial start date
01/12/2013
Overall trial end date
01/02/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men age at least 59 years
2. Partially edentulous, and wearing their third lower denture
3. Have the same maxillomandiblar relationship class one
4. The patients with non-vital tooth had acute pulpitis treated by root canal treatment
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
30
Participant exclusion criteria
Patients with systemic diseases
Recruitment start date
24/12/2013
Recruitment end date
12/08/2014
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
Albaha University
Al-Baha
00966
Saudi Arabia
Funders
Funder type
University/education
Funder name
Albaha University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
01/10/2015
Participant level data
Available on request
Results - basic reporting
Publication summary