Bio-HPP vs Cast Co-cr as Implant Framework

NCT05861388 | Completed

• 1 other identifier: Prosth16/06/02
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Edentulous Alveolar Ridge

Keywords

Bio-HPP; PEEK; Screw-Retained; Implant Framework

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• mechanical complications

  12 months after loading

Study Arms (2)

cobalt chrome implant framework

ACTIVE COMPARATOR

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

Procedure: implant placement

Bio-Hpp implant framework

EXPERIMENTAL

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

Procedure: implant placement

Interventions

implant placement PROCEDURE

2 implants were placed at position of lower 2nd premolar and 2nd molar

Also known as: final prosthesis was constructed on the implants

Bio-Hpp implant framework; cobalt chrome implant framework

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer at prosthodontic department

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: May 16, 2023
• Study Start: January 15, 2017
• Primary Completion: January 20, 2019
• Study Completion: July 22, 2020
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share