Prosthesis and Implant DentistryNCT04708132
Maintenance and Tissues Conditions of Fixed Screw-Retained Implant Prosthesis Versus Implant-Retained Ball Overdentures
A study testing Screw retained restoration and implant-retained ball overdentures in people with Prosthesis and Implant Dentistry, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this study was to compare the prosthetic maintenance requirements between implant-retained ball overdentures versus fixed screw- retained implant prosthesis. Clinical and radiographic changes in peri-implant tissue with using PGE2 as a PICF biomarker were also evaluated. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis and Implant Dentistry
- What is being tested?
- Screw retained restoration and implant-retained ball overdentures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Nov 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous patients have Angle Class I maxilla-mandibular relationship.
- Age range between 40 and 70.
- Maxillary and mandibular ridges with no history of fresh extraction.
- Sufficient bone volume to house four implants in each arch.
- Sufficient zone of keratinized attached mucosa >5mm over the crest of the upper and lower ridges.
Who cannot join
- the patients have a past history of head and neck radiation
- previous ridge augmentation or grafting
- Lack of any systemic diseases that could affect osseointegration of implants as uncontrolled diabetes , hypertension , and osteoporosis
- Heavy smokers who exceeding 20 cigarette/ day
- para-functional habits for example bruxism or clenching.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry , Kafrelshiekh university
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511
About this study
Official title: Prosthetic Maintenance and Peri- Implant Tissues Conditions of Fixed Screw- Retained Implant Prosthesis Versus Implant-Retained Ball Overdentures: A Randomized Clinical Trial
The aim of this study was to compare the prosthetic maintenance requirements between implant-retained ball overdentures versus fixed screw- retained implant prosthesis. Clinical and radiographic changes in peri-implant tissue with using PGE2 as a PICF biomarker were also evaluated. Selected patients had been divided into two groups:
- Group (I): twenty seven patients had received implant-Supported ball over dentures.
- Group (II): twenty-seven patients had received screw retained restorations Interventions and study procedures
Read more
Surgical and prosthetic procedures:
Surgical Procedures A radiopaque radiographic stent was formed and was positioned in the patient's mouth during cone beam scanning. Four implants were planned with two virtual replicas, in the place of the lateral incisor and the second premolar.
The stent was fabricated. After the healing period of four months finished, the patients were recalled and the super structure was fabricated according to the type of restoration Follow-up During the 12 months follow-up period, prosthodontic complications were recorded and calculated.
Postoperative care Along with a conventional oral hygiene assessment and functional checkup, follow up visits were scheduled every 6 months and up to 12 months total follow up period.
Clinical soft tissue measurements which include plaque index (PI), gingival index (GI), and PPD were measured at the mid-facial, mid-lingual, mid-mesial, and mid-distal aspects of each fixture using a graduated plastic probe to the nearest 0.5 mm. These clinical measurements were recorded after prosthesis delivery, 6 and 12 months postoperatively. The peri-implant marginal bone loss (MBL) was assessed radiographically after prosthesis delivery, 6 and 12 months postoperatively.
- Collection of peri-implant crevicular fluid (PICF) samples: PICF was collected.
- Conditions
- Prosthesis and Implant Dentistry
- Being tested
- Screw retained restoration, implant-retained ball overdentures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screw retained restorationProcedure or surgery
Hybrid prosthesis
implant-retained ball overdenturesProcedure or surgery
Removable prosthesis
| Study group | Role | What they receive |
|---|---|---|
| screw retained restorations | Active comparator | Not described Receives: Procedure: Screw retained restoration |
| implant-retained ball overdentures | Other | Not described Receives: Procedure: implant-retained ball overdentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of prosthetic complications
Measured: 12 months
Secondary outcomes (1)
changes in peri-implant tissue with using PGE2 as a PICF biomarker
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Jan 2019
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis and Implant DentistryStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Ahmed Ragheb, Kafrelsheikh University
- Investigators
- Nourhan Ragheb, PhD, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708132
- Sponsor's protocol ID
- KD/02/20
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Maintenance and Peri- Implant Tissues Conditions of Fixed Screw- Retained Implant Prosthesis Versus Implant-Retained Ball Overdentures: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04708132
- Acronym / sponsor ID
- KD/02/20
- Conditions
- Prosthesis and Implant Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 13 Jan 2021 (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 aim of this study was to compare the prosthetic maintenance requirements between implant-retained ball overdentures versus fixed screw- retained implant prosthesis. Clinical and radiographic changes in peri-implant tissue with using PGE2 as a PICF biomarker were also evaluated. Selected patients had been divided into two groups:
- Group (I): twenty seven patients had received implant-Supported ball over dentures.
- Group (II): twenty-seven patients had received screw retained restorations Interventions and study procedures
Surgical and prosthetic procedures:
Surgical Procedures A radiopaque radiographic stent was formed and was positioned in the patient's mouth during cone beam scanning. Four implants were planned with two virtual replicas, in the place of the lateral incisor and the second premolar.
The stent was fabricated. After the healing period of four months finished, the patients were recalled and the super structure was fabricated according to the type of restoration Follow-up During the 12 months follow-up period, prosthodontic complications were recorded and calculated.
Postoperative care Along with a conventional oral hygiene assessment and functional checkup, follow up visits were scheduled every 6 months and up to 12 months total follow up period.
Clinical soft tissue measurements which include plaque index (PI), gingival index (GI), and PPD were measured at the mid-facial, mid-lingual, mid-mesial, and mid-distal aspects of each fixture using a graduated plastic probe to the nearest 0.5 mm. These clinical measurements were recorded after prosthesis delivery, 6 and 12 months postoperatively. The peri-implant marginal bone loss (MBL) was assessed radiographically after prosthesis delivery, 6 and 12 months postoperatively.
- Collection of peri-implant crevicular fluid (PICF) samples: PICF was collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| screw retained restorations | Active comparator | Procedure: Screw retained restoration |
| implant-retained ball overdentures | Other | Procedure: implant-retained ball overdentures |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completely edentulous patients have Angle Class I maxilla-mandibular relationship.
- Age range between 40 and 70.
- Maxillary and mandibular ridges with no history of fresh extraction.
- Sufficient bone volume to house four implants in each arch.
- Sufficient zone of keratinized attached mucosa >5mm over the crest of the upper and lower ridges.
Key exclusion criteria (5 listed)
- the patients have a past history of head and neck radiation
- previous ridge augmentation or grafting
- Lack of any systemic diseases that could affect osseointegration of implants as uncontrolled diabetes , hypertension , and osteoporosis
- Heavy smokers who exceeding 20 cigarette/ day
- para-functional habits for example bruxism or clenching.
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 |
|---|---|---|
| Screw retained restorationHybrid prosthesis | Procedure or surgery | screw retained restorations |
| implant-retained ball overdenturesRemovable prosthesis | Procedure or surgery | implant-retained ball overdentures |
Primary outcome
Rate of prosthetic complications
Time frame: 12 months
1 secondary outcome
changes in peri-implant tissue with using PGE2 as a PICF biomarker
Time frame: 12 months
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 13 Jan 2021.
Related trials for Prosthesis and Implant Dentistry
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Recruiting
Passive Fit of Implant-Supported Complete-Arch Prostheses Using Digital Workflows
Prosthesis and Implant Dentistry
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.
Nourhan Ragheb, PhD principal investigator
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screw retained restoration and implant-retained ball overdentures in people with Prosthesis and Implant Dentistry, run by Kafrelsheikh University at 1 site in Egypt.
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 5 inclusion and 5 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 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Rate of prosthetic complications (time frame: 12 months). 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 13 Jan 2021.