Peri-ImplantitisNCT04543864
Soft Tissue Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Casted
A study testing Electric intraoral welding device and casting in people with Peri-Implantitis, run by Cairo University at 1 site in Egypt.
Trial summary
comparing the changes in the soft tissue around the implants that will be joined by a metal framework either with electric welding or with the conventional casting method Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Electric intraoral welding device and casting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2020to Nov 2021
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages range from 45 to 65 years old.
- Absence of any medical disorder that could complicate the Surgical phase or affect osseointegration.
- The patients must be completely edentulous.
- The patient must have enough bone height for implants minimum length of 10mm and a minimum diameter of 5 mm.
- Patients with good oral hygiene.
- Complete denture wearer.
- Adequate inter arch space for screw retained prosthesis.
- Absence of any intra-oral pathological condition.
Who cannot join
- Patients with recent extraction(less than three months).
- Patients with inflamed ridge or candida infection.
- Patients with flappy ridge.
- Parafunctional habits.
Trial locations and contacts
1 site in 1 country.
faculty of dentistry,cairo university Cairo university contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo University , Faculty of dentistry
Cairo, 11553
Faculty of dentistry Cairo university
About this study
Official title: Soft Tissue Changes Assessment in Screw-Retained Maxillary Implant Supported Complete Denture With Electric Welded Metal Framework Versus Casted One (RCT, Split Mouth Design)
comparing the changes in the soft tissue around the implants that will be joined by a metal framework either with electric welding or with the conventional casting method
Read the detailed description
as joining multiple implants by a metal framework considered a solid solution for edentulous arches , but in the same time the conventional method to weld this metal framework to the implants by casting technique in lab usually involves a several disadvantages eg. cost and time consuming in addition to laboratory errors, Thus , this study aims to find another method to weld the metal framework intraorally by an electric welding device
- Conditions
- Peri-Implantitis
- Being tested
- Electric intraoral welding device, casting
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric intraoral welding deviceDevice
welding metal framework to the implants in completely edentulous maxilla by electric welding device intraorally
castingDevice
casting the metal framework
| Study group | Role | What they receive |
|---|---|---|
| electric welded metal framework | Experimental | Not described Receives: Device: Electric intraoral welding device |
| conventional casted metal framework | Experimental | Not described Receives: Device: casting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft Tissue Changes Assessment
Primary outcome is the probing depth which will be measured using the periodontal probe (unit mm) around the implant to check the changes that may occur in the peri-implant soft tissues
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 posted10 Sep 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamsa Khalid Lafta, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543864
- Sponsor's protocol ID
- 13420
- Status last verified
- Oct 2020
- First submitted
- 26 Aug 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Changes Assessment in Screw-Retained Maxillary Implant Supported Complete Denture With Electric Welded Metal Framework Versus Casted One (RCT, Split Mouth Design)
- ClinicalTrials.gov ID
- NCT04543864
- Acronym / sponsor ID
- 13420
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 10 Sep 2020 (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.
comparing the changes in the soft tissue around the implants that will be joined by a metal framework either with electric welding or with the conventional casting method
Detailed description
as joining multiple implants by a metal framework considered a solid solution for edentulous arches , but in the same time the conventional method to weld this metal framework to the implants by casting technique in lab usually involves a several disadvantages eg. cost and time consuming in addition to laboratory errors, Thus , this study aims to find another method to weld the metal framework intraorally by an electric welding device
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electric welded metal framework | Experimental | Device: Electric intraoral welding device |
| conventional casted metal framework | Experimental | Device: casting |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages range from 45 to 65 years old.
- Absence of any medical disorder that could complicate the Surgical phase or affect osseointegration.
- The patients must be completely edentulous.
- The patient must have enough bone height for implants minimum length of 10mm and a minimum diameter of 5 mm.
- Patients with good oral hygiene.
Key exclusion criteria (4 listed)
- Patients with recent extraction(less than three months).
- Patients with inflamed ridge or candida infection.
- Patients with flappy ridge.
- Parafunctional habits.
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 |
|---|---|---|
| Electric intraoral welding devicewelding metal framework to the implants in completely edentulous maxilla by electric welding device intraorally | Device | electric welded metal framework |
| castingcasting the metal framework | Device | conventional casted metal framework |
Primary outcome
Soft Tissue Changes Assessment
Time frame: 12 months
Primary outcome is the probing depth which will be measured using the periodontal probe (unit mm) around the implant to check the changes that may occur in the peri-implant soft tissues
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- 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.
faculty of dentistry,cairo university Cairo university contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric intraoral welding device and casting in people with Peri-Implantitis, run by Cairo 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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact faculty of dentistry,cairo university Cairo university (+20235676105, dentmail@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft Tissue Changes Assessment (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 8 Oct 2020.