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It is a randomized control clinical trial in which maxillary and mandibular dentures will be constructed, two implants will be inserted in the inter foraminal region in the edentulous mandible and immediate loading will be done. We will be comparing peri-implant marginal bone loss of two immediately loaded implants retaining mandibular overdentures with ball attachment versus intra oral welding titanium bar. Patient satisfaction will be assessed using oral health related quality of life.
The patients will be divided in two groups, each group will receive maxillary and mandibular conventional heat cured acrylic resin complete dentures, which will be duplicated and provided by radio-opaque resin at the proposed implant sites to act as radiographic stents. Only patients with a D2 or D3 bone density will be included in the study. This will be confirmed by their cone beam computed tomographic (CBCT) scans of the mandible, while wearing radiographic stents.
The CBCT will be used to ensure sufficient bone width at the proposed implant sites, namely canine regions for implant diameter 3.7. Diagnostic set ups for all patients will be prepared to ensure a crown height space of at least 12 mm to accommodate the ball attachments for group I and intra oral welding bar for group II. Each group will receive two implants in the canine region through using surgical stent and immediate loading will be done.
Group B: immediate loading will be done using ball attachment and soft liners acting as female part for mandibular overdenture.
Group I: immediate loading will be done using intra oral welding titanium bar with 2 mm diameter and soft liner acting as a female part for mandibular overdenture.
For each group, marginal bone loss around the implants will be assessed at time of denture delivery and six months later. Patient satisfaction will be assessed using oral health related quality of life using (OHRQOL 14)
Study population
Patients' selection:
Fifty four edentulous patients will be selected from the out-patient clinic of Removable prosthodontics department, Faculty of Dentistry, Ain Shams University according to inclusion and exclusion criteria. This research will be reviewed by the research ethics committee faculty of dentistry Ain Shams University
Patients' approval:
Study procedure
Patients' history:
Patients' examination:
- Extra oral examination:
It will be carried-out to detect any facial abnormalities, signs of inflammation and TMJ disorders as pain, clicking and limited mouth opening as well as maximum opening.
- Intra-oral examination:
Visual examination of the denture bearing area with no flabby tissues, mucous membrane of the cheeks, lips, palate and tongue. They will be checked for no ulceration or signs of inflammation also exclude bony protuberance presence.
Radiographic evaluation and surgical guide construction:
Randomization and allocation concealment:
Patients will be selected randomly. The method requires the preparation of opaque sealed envelopes, containing the letter "B" and the letter "I" to represent ball attachment and the bar attachment groups respectively.
Patients will be selected according to inclusion and exclusion criteria.
Surgical procedures:
Prosthetic insertion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mplant supported overdenture by ball attachment | Placebo Comparator | immediate loaded implant supported overdenture by ball attachment |
|
| implant supported overdenture by bar | Active Comparator | immediate loaded implant supported overdenture by intraoral welding titanium bar splinted two implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| implant supported overdenture by ball | Procedure | overdenture supported by two implant with ball attachment |
|
| Measure | Description | Time Frame |
|---|---|---|
| marginal bone loss measurement | marginal bone loss will be measured mesial and distal to the implant by radiographic cone paralling technique | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction | patient satisfaction will be measured by oral health of quality of life questionnaire | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed MA Mohamed, BDS MSc,MD | Contact | 01111191337 | ahmedmostafa@dent.asu.edu.eg | |
| Amr MO El fikky, BDS MSc | Contact | 01144224292 | aaa.fiky@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed MA Mohamed, BDS MSc MD | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry Ain Shams University | Cairo | 11361 | Egypt |
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completely edentulous patients treated with overdenture retained by immediately loaded implant in the canine region
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Blinding will be done by the outcomes assessor and one of the study authors will remove the prosthetic part before measuring crestal bone loss by outcome assessor through cone paralling technique. Blinding of the outcomes assessor for assessment by oral health questionnaire will be done as well
| implant supported overdenture by bar | Procedure | overdenture supported by two implant splinted by intraoral welding titanuim bar |
|