Bio-HPP vs Cast Co-cr as Implant Framework

Short Term Comparative Evaluation of Bio-HPP and Cast Cobalt-chromium as a Framework for Implant-supported Prostheses: A Split-mouth Clinical Randomized Study

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)

Study Overview

• Status: Completed
• Conditions: Edentulous Alveolar Ridge
• Intervention / Treatment: Procedure: implant placement

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
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.	12 months
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	12 months
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mechanical complications	framework fracture, screw loosening, screw fracture and chipping or fracture of veneer layer	12 months after loading

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Actual): January 20, 2019
• Study Completion (Actual): July 22, 2020

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: PEEK; Bio-HPP; Screw-Retained; Implant Framework
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: Prosth16/06/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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