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Maintenance and Tissues Conditions of Fixed Screw-Retained Implant Prosthesis Versus Implant-Retained Ball Overdentures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04708132
Recruitment Status : Completed
First Posted : January 13, 2021
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Nourhan Ahmed Ragheb, Kafrelsheikh University

Study Description
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Brief Summary:

The aim of this study was to compare the prosthetic maintenance requirements between implant-retained ball overdentures versus fixed screw- retained implant prosthesis. Clinical and radiographic changes in peri-implant tissue with using PGE2 as a PICF biomarker were also evaluated. Selected patients had been divided into two groups:

  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.


Condition or disease Intervention/treatment Phase
Prosthesis and Implant Dentistry Procedure: Screw retained restoration Procedure: implant-retained ball overdentures Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prosthetic Maintenance and Peri- Implant Tissues Conditions of Fixed Screw- Retained Implant Prosthesis Versus Implant-Retained Ball Overdentures: A Randomized Clinical Trial
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : November 1, 2020
Actual Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: screw retained restorations Procedure: Screw retained restoration
Hybrid prosthesis
implant-retained ball overdentures Procedure: implant-retained ball overdentures
Removable prosthesis


Outcome Measures
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Primary Outcome Measures :
  1. Rate of prosthetic complications [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. changes in peri-implant tissue with using PGE2 as a PICF biomarker [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Completely edentulous patients have Angle Class I maxilla-mandibular relationship.
  • 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:

  • the patients have a past history of head and neck radiation
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04708132


Locations
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Egypt
Faculty of Dentistry , Kafrelshiekh university
Kafr El Sheikh, Egypt, 33511
Sponsors and Collaborators
Kafrelsheikh University
Investigators
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Principal Investigator: Nourhan Ragheb, PhD Kafrelsheikh University
More Information
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Responsible Party: Nourhan Ahmed Ragheb, principal invistigator, Kafrelsheikh University
ClinicalTrials.gov Identifier: NCT04708132    
Other Study ID Numbers: KD/02/20
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No