Back to resultsBio-HPP vs Cast Co-cr as Implant Framework
Primary Purpose
Edentulous Alveolar Ridge
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
implant placement
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Alveolar Ridge focused on measuring Bio-HPP, PEEK, Screw-Retained, Implant Framework
Eligibility Criteria
Inclusion Criteria: Mandibular posterior edentulous with the first premolar as the last standing abutment tooth bilaterally. All patients were edentulous for at least 6 months from the last extraction. The bone height of the alveolar ridge was not less than 12 mm above the inferior alveolar canal and the buccolingual width of the alveolar ridge at the prospective implant site was not less than 6 mm. The opposing arch was almost dentulous, and any missing teeth were restored using a fixed partial denture. Adequate interarch space at least 5mm between the opposing dentition and the mandibular edentulous space. Remaining teeth were in good periodontal condition. Maintaining good oral hygiene and were ready to cooperate throughout the study. Exclusion Criteria: Patients with active infection or inflammation or flabby tissue in the areas intended for implant placement. Those patients with systemic diseases that may influence soft or hard tissue healing. Patients with a history of radiation therapy in the head and neck region. Neurological or psychiatric handicap patients that could interfere with good oral hygiene. Heavy smokers and drug abusers. Patients with severe clenching or bruxism.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
cobalt chrome implant framework
Bio-Hpp implant framework
Arm Description
the participants received Co-Cr based screw-retained implant supported prosthesis at one side of the lower jaw
The participants received Bio-Hpp based screw-retained implant-supported prosthesis at the other side
Outcomes
Primary Outcome Measures
marginal bone loss around implants
Marginal bone level was measured from the implant shoulder to the first bone to implant contact on the mesial and distal sides of the implant on digital standardized periapical radiograph using the long cone paralleling technique
modified plaque index
Plaque adherent to the implants was quantified at four surfaces: buccal, lingual, mesial, and distal using a plastic periodontal probe after air drying for the implant and gingiva. The four sides for each implant were scored 0-3 according to the following criteria:
Score 0: No plaque detected. Score 1: Plaque can be detected by running a probe across the marginal surface of the implant.
Score 2: Plaque can be seen by naked eye. Score 3: Abundance of plaque.
modified bleeding index
A plastic periodontal probe was passed along the gingival margin adjacent to the implant and the following scores were given according to Mombelli and Lang Score 0: No bleeding with slight pressure on the mucosa using periodontal probe.
Score 1: Isolated bleeding spots visible. Score 2: Blood forms a confluent red line on margin. Score 3: Heavy or profuse bleeding
probing depth
., the peri- implant probing pocket depth is measured around the surfaces of the implants in four areas (mid-buccal, mid-lingual, med-mesial, mid-distal) using plastic periodontal probe* which was inserted with light force and parallel to long axis of implant
Secondary Outcome Measures
mechanical complications
framework fracture, screw loosening, screw fracture and chipping or fracture of veneer layer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05861388
Brief Title
Bio-HPP vs Cast Co-cr as Implant Framework
Official Title
Short Term Comparative Evaluation of Bio-HPP and Cast Cobalt-chromium as a Framework for Implant-supported Prostheses: A Split-mouth Clinical Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2017 (Actual)
Primary Completion Date
January 20, 2019 (Actual)
Study Completion Date
July 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this study was to assess the effect of Bio-Hpp versus Co-Cr custom abutments in fixed-detachable implant-supported mandibular partial dentures clinically and radiographically in Class I Kennedy classification (split-mouth study)
Detailed Description
Participants with bilateral partial edentulism in the posterior mandible received two implants at the positions of the second premolar and second molar on both sides; one side was restored with BioHpp based screw-retained FDP (test group) and the other side was restored with Co-Cr based screw-retained FDP (control group). All patients were clinically examined at the time of prosthesis insertion, and 6,12 months later for fracture of implant or framework, fracture, or looseness of the screw, veneer chipping, and fractures, modified bleeding index, modified plaque index, peri-implant probing depth, as well as radiographically for marginal bone loss
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Alveolar Ridge
Keywords
Bio-HPP, PEEK, Screw-Retained, Implant Framework
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cobalt chrome implant framework
Arm Type
Active Comparator
Arm Description
the participants received Co-Cr based screw-retained implant supported prosthesis at one side of the lower jaw
Arm Title
Bio-Hpp implant framework
Arm Type
Experimental
Arm Description
The participants received Bio-Hpp based screw-retained implant-supported prosthesis at the other side
Intervention Type
Procedure
Intervention Name(s)
implant placement
Other Intervention Name(s)
final prosthesis was constructed on the implants
Intervention Description
2 implants were placed at position of lower 2nd premolar and 2nd molar
Primary Outcome Measure Information:
Title
marginal bone loss around implants
Description
Marginal bone level was measured from the implant shoulder to the first bone to implant contact on the mesial and distal sides of the implant on digital standardized periapical radiograph using the long cone paralleling technique
Time Frame
12 months
Title
modified plaque index
Description
Plaque adherent to the implants was quantified at four surfaces: buccal, lingual, mesial, and distal using a plastic periodontal probe after air drying for the implant and gingiva. The four sides for each implant were scored 0-3 according to the following criteria:
Score 0: No plaque detected. Score 1: Plaque can be detected by running a probe across the marginal surface of the implant.
Score 2: Plaque can be seen by naked eye. Score 3: Abundance of plaque.
Time Frame
12 months
Title
modified bleeding index
Description
A plastic periodontal probe was passed along the gingival margin adjacent to the implant and the following scores were given according to Mombelli and Lang Score 0: No bleeding with slight pressure on the mucosa using periodontal probe.
Score 1: Isolated bleeding spots visible. Score 2: Blood forms a confluent red line on margin. Score 3: Heavy or profuse bleeding
Time Frame
12 months
Title
probing depth
Description
., the peri- implant probing pocket depth is measured around the surfaces of the implants in four areas (mid-buccal, mid-lingual, med-mesial, mid-distal) using plastic periodontal probe* which was inserted with light force and parallel to long axis of implant
Time Frame
12 months
Secondary Outcome Measure Information:
Title
mechanical complications
Description
framework fracture, screw loosening, screw fracture and chipping or fracture of veneer layer
Time Frame
12 months after loading
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mandibular posterior edentulous with the first premolar as the last standing abutment tooth bilaterally.
All patients were edentulous for at least 6 months from the last extraction.
The bone height of the alveolar ridge was not less than 12 mm above the inferior alveolar canal and the buccolingual width of the alveolar ridge at the prospective implant site was not less than 6 mm.
The opposing arch was almost dentulous, and any missing teeth were restored using a fixed partial denture.
Adequate interarch space at least 5mm between the opposing dentition and the mandibular edentulous space.
Remaining teeth were in good periodontal condition.
Maintaining good oral hygiene and were ready to cooperate throughout the study.
Exclusion Criteria:
Patients with active infection or inflammation or flabby tissue in the areas intended for implant placement.
Those patients with systemic diseases that may influence soft or hard tissue healing.
Patients with a history of radiation therapy in the head and neck region.
Neurological or psychiatric handicap patients that could interfere with good oral hygiene.
Heavy smokers and drug abusers.
Patients with severe clenching or bruxism.
12. IPD Sharing Statement
Plan to Share IPD
No
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Bio-HPP vs Cast Co-cr as Implant Framework
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