The immediate implant-supported mandibular overdentures with cusped and cuspless tooth

ISRCTN ISRCTN10121553
DOI https://doi.org/10.1186/ISRCTN10121553
Secondary identifying numbers N/A
Submission date
31/08/2015
Registration date
07/09/2015
Last edited
20/04/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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. These implants provide a strong foundation for fixed (permanent) or removable false teeth and, as long as they are looked after well, are very long lasting. Many people prefer dental implants to traditional dentures because they are more hardwearing and have a more realistic appearance. The artificial teeth which are used for overdentures come in a variety of forms. One of the main variations is related to cusps (the pointed end of the tooth). Cusped overdentures (also known as anatomic) are designed to imitate the natural tooth form, whereas cuspless overdentures (or non-anatomic) is essentially flat and designed to improve the function of chewing. The aim of this study is to compare the effects of cusped and cuspless implants on the health of the surrounding bone tissues in the mouth.

Who can participate?
Healthy adults over 40 with missing teeth for more than 3 years, who have refused removable partial dentures.

What does the study involve?
Participants are randomly allocated into two groups. Both groups have implants inserted after tooth extraction. The first group is given overdentures with cusped teeth, and the second group is given overdentures with cuspless teeth. Once the implants have been fitted, the healing process and how well they fit is measured at three, six, nine and twelve months. Participants are also asked to describe pain levels at these times.

What are the possible benefits and risks of participating?
Benefits of participating are that patients are treated using two advanced methods at no cost. There are no risks of participating.

Where is the study run from?
Al-Azhar University-Assiut Branch (Egypt)

When is the study starting and how long is it expected to run for?
September 2013 to September 2014

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

Who is the main contact?
1. Dr Hammdi Hakimi (Public)
yahio2000@yahoo.com
2. Professor Khalid Ahmad Omar Arafa (Scientific)
drkhalidarafa@yahoo.com

Contact information

Dr Hammdi Hakimi
Public

Al-Baha, Saudi Arabia
Al-Baha
00966
Saudi Arabia

ORCiD logoORCID ID 0000-0002-3597-5073
Phone +966 532 153553
Email yahio2000@yahoo.com
Prof Khalid Ahmad Omar Arafa
Scientific

Dental Health Department
Faculty of Applied Medical Sciences
Albaha University
Albaha
65536
Saudi Arabia

ORCiD logoORCID ID 0000-0002-3597-5073
Phone +966 533 88866
Email drkhalidarafa@yahoo.com

Study information

Study designA randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe impact of immediate implant-supported mandibular overdentures with cusped and cuspless tooth on bone tissues
Study objectivesThe immediate implant-supported mandibular overdentures with cusped teeth is better than cuspless teeth.
Ethics approval(s)Dental Health Department of the Faculty of Applied Medical Sciences (Albaha University), 04/08/2013
Health condition(s) or problem(s) studiedThis study aimed to examine the impact of immediate implant-supported mandibular overdentures with cusped or cuspless tooth on surrounding bone tissues.
InterventionThe randomization of selected patients was by lottery selection after giving each patient a number in a list, and then randomly the 20 patients were divided into two groups, 10 patients for each group.
Group 1: Rehabilitation with immediate implants (the implant inserted immediately after extraction) loaded with overdentures with cusped teeth.
Group 2: Rehabilitated with immediate implants (implants inserted immediately after extraction) loaded with overdentures with cuspless teeth.
Following flap elevation and the removal of a tooth and implant installation, inside the socket then the clinical measurements were made to characterize the dimension of the surrounding bone walls, as well as the marginal defect. There were no membranes or filler material was used. The flaps were subsequently replaced and secured with sutures in such a way that the healing cap of the implant was exposed to the oral environment. After 3 months of healing a re-entry procedure was performed and the clinical measurements were repeated.
Intervention typeProcedure/Surgery
Primary outcome measureCrestal bone loss observed over one year, at 3, 6, 9 and 12 months. The measurement of crestal bone loss by periapical radiographs was evaluated by the masial and distal marginal bone height around the abutments (implant) from the radiograph of each patient as follow; two points were marked one at apex of implant and anther at the tip of the implant, a line (A) was drown connecting the 2 points then the tangent (b) to the tip of tooth, marginal bone height was measured by a dial caliper from mesial and distal alveolar crest to line (b), and measurements on serial radiographs were compared and the results were statistically analyzed as mean and percent.
Secondary outcome measures1. Periapical lesions measured in each cross-section from the widest and deepest part of the lesion by the researcher using a precision digital caliper with an accuracy of up to 0.01 mm, at 3, 6, 9 and 12 months.
2. Pain measured using visual analog scale (VAS) at 3, 6, 9 and 12 months
3. Neural sensibility measured using a pulp sensibility test, which includes an electric test, which extrapolates pulp health from sensory response, at 3, 6, 9 and 12 months
4. Mobility of implants measured according to the periotest, siemens dental bensheim, Germany at 3, 6, 9 and 12 months.
Overall study start date01/09/2013
Completion date12/09/2014

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants20 Edentoulus patients
Key inclusion criteria1. Aged over 40 years
2. Free from any systematic diseases
3. Non-smoker
4. Jaw relation angle class one
5. Refused removable partial dentures
6. Edentulous more than 3 years
7. Hopeless mandibular teeth
Key exclusion criteria1. Diabetes
2. Hypertension
3. Patients who prefer the removable partial dentures
4. Immunodeficient patients
Date of first enrolment01/10/2013
Date of final enrolment01/09/2014

Locations

Countries of recruitment

  • Egypt

Study participating centre

Al-Azhar University-Assiut Branch
Dental Clinic
Faculty of Dentistry
Assuit
71524
Egypt

Sponsor information

Albaha University
Not defined

The faculty of Applied Medical Sciences
Prince Mohammad Bin Saud
N/A
00966
Saudi Arabia

Phone +966 553 366688
Email drkhalidrafa@yahoo.com
ROR logo "ROR" https://ror.org/0403jak37

Funders

Funder type

Not defined

Albaha University

No information available

Results and Publications

Intention to publish date01/10/2015
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planIntend to publish this study in ISI journals
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2016 Yes No

Editorial Notes

20/04/2018: Publication reference added.
19/10/2015: Trial participating centre address has changed from Albaha University Dental Clinic to Faculty of Dentistry at Al-Azhar University-Assiut Branch.