Bio-HPP vs Cast Co-cr as Implant Framework

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT05861388
Collaborator
(none)
15
2
42.2

Study Details

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)

Condition or Disease Intervention/Treatment Phase
  • Procedure: implant placement
N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 15, 2017
Actual Primary Completion Date :
Jan 20, 2019
Actual Study Completion Date :
Jul 22, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: cobalt chrome implant framework

the participants received Co-Cr based screw-retained implant supported prosthesis at one side of the lower jaw

Procedure: implant placement
2 implants were placed at position of lower 2nd premolar and 2nd molar
Other Names:
  • final prosthesis was constructed on the implants
  • Experimental: Bio-Hpp implant framework

    The participants received Bio-Hpp based screw-retained implant-supported prosthesis at the other side

    Procedure: implant placement
    2 implants were placed at position of lower 2nd premolar and 2nd molar
    Other Names:
  • final prosthesis was constructed on the implants
  • Outcome Measures

    Primary Outcome Measures

    1. marginal bone loss around implants [12 months]

      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

    2. modified plaque index [12 months]

      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.

    3. modified bleeding index [12 months]

      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

    4. probing depth [12 months]

      ., 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

    1. mechanical complications [12 months after loading]

      framework fracture, screw loosening, screw fracture and chipping or fracture of veneer layer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tanta University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marwa Mohammed Amer, assistant lecturer at prosthodontic department, Tanta University
    ClinicalTrials.gov Identifier:
    NCT05861388
    Other Study ID Numbers:
    • Prosth16/06/02
    First Posted:
    May 16, 2023
    Last Update Posted:
    May 16, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Marwa Mohammed Amer, assistant lecturer at prosthodontic department, Tanta University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 16, 2023