Edentulous Alveolar RidgeNCT05861388
Bio-HPP vs Cast Co-cr as Implant Framework
A study testing implant placement in people with Edentulous Alveolar Ridge, run by Tanta University.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2017to 22 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- implant placement
- Keywords
- Bio-HPP, PEEK, Screw-Retained, Implant Framework
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placementProcedure or surgery
Also called final prosthesis was constructed on the implants
2 implants were placed at position of lower 2nd premolar and 2nd molar
| Study group | Role | What they receive |
|---|---|---|
| cobalt chrome implant framework | Active comparator | the participants received Co-Cr based screw-retained implant supported prosthesis at one side of the lower jaw Receives: Procedure: implant placement |
| Bio-Hpp implant framework | Experimental | The participants received Bio-Hpp based screw-retained implant-supported prosthesis at the other side Receives: Procedure: implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 12 months
Secondary outcomes (1)
mechanical complications
framework fracture, screw loosening, screw fracture and chipping or fracture of veneer layer
Measured: 12 months after loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 Jan 2017
- Primary completion20 Jan 2019
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohammed Amer, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861388
- Sponsor's protocol ID
- Prosth16/06/02
- Status last verified
- May 2023
- First submitted
- 20 Oct 2021
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05861388
- Acronym / sponsor ID
- Prosth16/06/02
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- Bio-HPP, PEEK, Screw-Retained, Implant Framework
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cobalt chrome implant framework | Active comparator | Procedure: implant placementthe participants received Co-Cr based screw-retained implant supported prosthesis at one side of the lower jaw |
| Bio-Hpp implant framework | Experimental | Procedure: implant placementThe participants received Bio-Hpp based screw-retained implant-supported prosthesis at the other side |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Mandibular posterior edentulous with the first premolar as the last standing abutment tooth bilaterally.
Key exclusion criteria (6 listed)
- Patients with active infection or inflammation or flabby tissue in the areas intended for implant placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implant placementAlso: final prosthesis was constructed on the implants2 implants were placed at position of lower 2nd premolar and 2nd molar | Procedure or surgery | Bio-Hpp implant framework, cobalt chrome implant framework |
Primary outcome
marginal bone loss around implants
Time frame: 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
modified plaque index
Time frame: 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.
modified bleeding index
Time frame: 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
probing depth
Time frame: 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
1 secondary outcome
mechanical complications
Time frame: 12 months after loading
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing implant placement in people with Edentulous Alveolar Ridge, run by Tanta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal bone loss around implants (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.