Maintenance and Tissues Conditions of Fixed Screw-Retained Implant Prosthesis Versus Implant-Retained Ball Overdentures
NCT ID: NCT04708132
Last Updated: 2021-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2019-01-01
2020-11-01
Brief Summary
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1. Group (I): twenty seven patients had received implant-Supported ball over dentures.
2. Group (II): twenty-seven patients had received screw retained restorations Interventions and study procedures
Surgical and prosthetic procedures:
Surgical Procedures A radiopaque radiographic stent was formed and was positioned in the patient's mouth during cone beam scanning. Four implants were planned with two virtual replicas, in the place of the lateral incisor and the second premolar.
The stent was fabricated. After the healing period of four months finished, the patients were recalled and the super structure was fabricated according to the type of restoration Follow-up During the 12 months follow-up period, prosthodontic complications were recorded and calculated.
Postoperative care Along with a conventional oral hygiene assessment and functional checkup, follow up visits were scheduled every 6 months and up to 12 months total follow up period.
Clinical soft tissue measurements which include plaque index (PI), gingival index (GI), and PPD were measured at the mid-facial, mid-lingual, mid-mesial, and mid-distal aspects of each fixture using a graduated plastic probe to the nearest 0.5 mm. These clinical measurements were recorded after prosthesis delivery, 6 and 12 months postoperatively. The peri-implant marginal bone loss (MBL) was assessed radiographically after prosthesis delivery, 6 and 12 months postoperatively.
• Collection of peri-implant crevicular fluid (PICF) samples: PICF was collected.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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screw retained restorations
Screw retained restoration
Hybrid prosthesis
implant-retained ball overdentures
implant-retained ball overdentures
Removable prosthesis
Interventions
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Screw retained restoration
Hybrid prosthesis
implant-retained ball overdentures
Removable prosthesis
Eligibility Criteria
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Inclusion Criteria
* Age range between 40 and 70.
* Maxillary and mandibular ridges with no history of fresh extraction.
* Sufficient bone volume to house four implants in each arch.
* Sufficient zone of keratinized attached mucosa \>5mm over the crest of the upper and lower ridges.
Exclusion Criteria
* previous ridge augmentation or grafting
* Lack of any systemic diseases that could affect osseointegration of implants as uncontrolled diabetes , hypertension , and osteoporosis
* Heavy smokers who exceeding 20 cigarette/ day
* para-functional habits for example bruxism or clenching.
40 Years
70 Years
ALL
Yes
Sponsors
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Kafrelsheikh University
OTHER
Responsible Party
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Nourhan Ahmed Ragheb
principal invistigator
Principal Investigators
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Nourhan Ragheb, PhD
Role: PRINCIPAL_INVESTIGATOR
Kafrelsheikh University
Locations
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Faculty of Dentistry , Kafrelshiekh university
Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt
Countries
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Other Identifiers
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KD/02/20
Identifier Type: -
Identifier Source: org_study_id
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