CClinicalTrials.gg
CompletedNCT05861388Updated May 16, 2023

Bio-HPP vs Cast Co-cr as Implant Framework

An interventional study of implant placement in Edentulous Alveolar Ridge, sponsored by Tanta University. Completed. Open to participants aged 40 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-16.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 9 months after the study started (first participant enrolled Jan 2017, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
40 Years to 55 Years
Sex
All
01

Study 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)

Read the 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

02

Conditions studied

  • Edentulous Alveolar Ridge

Browse trials for

Keywords

  • Bio-HPP
  • PEEK
  • Screw-Retained
  • Implant Framework
03

In context

Mouth, Edentulous

244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.

This study's enrollment of 15 is below the median of 30 across 187 interventional studies indexed under Mouth, Edentulous.

Browse Mouth, Edentulous studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 55 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
15 participants (actual)

Study arms

  • 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

  • Experimental
    Bio-Hpp implant framework

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

    Procedure: implant placement

Interventions

  • Procedureimplant placement

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

    Also known as: final prosthesis was constructed on the implants

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

  3. 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

    Time frame: 12 months

  4. 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

    Time frame: 12 months

Secondary outcomes

  1. mechanical complications

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

    Time frame: 12 months after loading

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05861388
Lead sponsor
Tanta University
Responsible party
Marwa Mohammed Amer (assistant lecturer at prosthodontic department, Tanta University) — Principal investigator
First posted
May 16, 2023
Start date
Jan 15, 2017
Primary completion
Jan 20, 2019
Completion
Jul 22, 2020
Last update
May 16, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion