Prosthesis DurabilityNCT05289752
Direct Versus Indirect Pick up of the Locator Retentive Caps:(Within-patient Study)
A study testing dental implants in the mandible and locator attachment and overdenture in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
Trial summary
The purpose of this study will be to evaluate the effect of direct and indirect pick up of the locator retentive caps and compare the clinical results with those of the manufacturer retentive force. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Durability
- What is being tested?
- dental implants in the mandible and locator attachment and overdenture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2021to 16 Mar 2023
- 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
- ● Free from any systemic disease that may interfere with the osseointegration of implants.
- Patients will have completely edentulous maxilla and mandible for at least 6 months after the last extraction.
- Patients will have normal maxilla mandibular relationships.
- Mandibular arch with residual alveolar ridges covered with firmly attached mucosa.
- The width of the mandibular ridge in the canine area will be sufficient for the installation of the implants in parallel anteroposterior and mesiodistal directions.
Who cannot join
- medically compromised patients smokers uncontrolled metabolic diseases ( diabetes mellitus ) uncooperative patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Direct Versus Indirect Pick up of the Locator Retentive Caps for Two Implant-retained Mandibular Overdenture: Calibration of the Manufacturer Retentive Force and the Clinical Retention (Within-patient Study)
The purpose of this study will be to evaluate the effect of direct and indirect pick up of the locator retentive caps and compare the clinical results with those of the manufacturer retentive force.
Read the detailed description
Patient selection:
For this study, 30 patients were selected from the clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University.
According to pick up technique for the locator retentive caps, the overdentures will be classified into two groups as follows; Group1: The retentive caps will be picked up by indirect method on the cast then by the direct method Group2: The retentive caps will be picked up in the patient by the direct method first then by the indirect method.
For both groups, the clinical retention will be measured after using pink and blue retentive inserts respectively.
All implants were inserted using computer-guided implant surgery and conventional loading protocol was used.
Evaluation methods The clinical retention of each insert will be calibrated as regards the manufacturer's value.
Also, the laboratory retention will be assessed for the two groups and calibrated as regards the manufacturer's value.
Measurements will be done immediately, three and six months after each overdenture insertion.
- Conditions
- Prosthesis Durability
- Being tested
- dental implants in the mandible, locator attachment and overdenture
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implants in the mandibleProcedure or surgery
placement of two interforaminal dental implants in the canine region in the mandible
locator attachment and overdentureDevice
placement of locator attachment and insertion of mandibular overdenture
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | GroupI: The retentive caps will be picked up by the indirect method on the cast first, then by the direct method. Receives: Procedure: dental implants in the mandible; Device: locator attachment and overdenture |
| Group II | Active comparator | GroupII: The retentive caps will be picked up by the direct method on the cast first, then by the indirect method. Receives: Procedure: dental implants in the mandible; Device: locator attachment and overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of overdenture retention
measuring the clinical retention of the locator retained mandibular overdenture by forcemeter
Measured: three months
Secondary outcomes (4)
marginal bone loss
measuring crestal bone loss around dental implants in mm by digital radiography
Measured: one year
plaque index
measuring plaque around dental implants using scoring system: score 0; absence plaque , score 1; plaque only detected by a probe passing through the smooth marginal surface of the implant, score 2; plaque can be recognized by naked eye, and score 3; plenty of soft matter.
Measured: one year
gingival index
measuring gingival bleeding using scoring system: 0; no bleeding when a periodontal probe is passed along the mucosal margin, 1;isolated bleeding spots visible, 2; blood forms a confluent red line on the mucosal margin, 3;heavy or profuse bleeding
Measured: one year
pocket depth
measuring pocket depth around dental implants in mm using periodontal probe
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start30 Aug 2021
- Primary completion7 Aug 2022
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis DurabilityStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289752
- Sponsor's protocol ID
- A17030821
- Status last verified
- Feb 2023
- First submitted
- 27 Feb 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Versus Indirect Pick up of the Locator Retentive Caps for Two Implant-retained Mandibular Overdenture: Calibration of the Manufacturer Retentive Force and the Clinical Retention (Within-patient Study)
- ClinicalTrials.gov ID
- NCT05289752
- Acronym / sponsor ID
- A17030821
- Conditions
- Prosthesis Durability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 7 Aug 2022 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 21 Mar 2022 (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 will be to evaluate the effect of direct and indirect pick up of the locator retentive caps and compare the clinical results with those of the manufacturer retentive force.
Detailed description
Patient selection:
For this study, 30 patients were selected from the clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University.
According to pick up technique for the locator retentive caps, the overdentures will be classified into two groups as follows; Group1: The retentive caps will be picked up by indirect method on the cast then by the direct method Group2: The retentive caps will be picked up in the patient by the direct method first then by the indirect method.
For both groups, the clinical retention will be measured after using pink and blue retentive inserts respectively.
All implants were inserted using computer-guided implant surgery and conventional loading protocol was used.
Evaluation methods The clinical retention of each insert will be calibrated as regards the manufacturer's value.
Also, the laboratory retention will be assessed for the two groups and calibrated as regards the manufacturer's value.
Measurements will be done immediately, three and six months after each overdenture insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: dental implants in the mandible, Device: locator attachment and overdentureGroupI: The retentive caps will be picked up by the indirect method on the cast first, then by the direct method. |
| Group II | Active comparator | Procedure: dental implants in the mandible, Device: locator attachment and overdentureGroupII: The retentive caps will be picked up by the direct method on the cast first, then by the indirect method. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ● Free from any systemic disease that may interfere with the osseointegration of implants.
Key exclusion criteria (1 listed)
- medically compromised patients smokers uncontrolled metabolic diseases ( diabetes mellitus ) uncooperative patients
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 |
|---|---|---|
| dental implants in the mandibleplacement of two interforaminal dental implants in the canine region in the mandible | Procedure or surgery | Group I, Group II |
| locator attachment and overdentureplacement of locator attachment and insertion of mandibular overdenture | Device | Group I, Group II |
Primary outcome
measurement of overdenture retention
Time frame: three months
measuring the clinical retention of the locator retained mandibular overdenture by forcemeter
4 secondary outcomes
marginal bone loss
Time frame: one year
plaque index
Time frame: one year
gingival index
Time frame: one year
pocket depth
Time frame: one year
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 20 Apr 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental implants in the mandible and locator attachment and overdenture in people with Prosthesis Durability, run by Mansoura 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 1 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 20 Apr 2023. 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?
measurement of overdenture retention (time frame: three 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 20 Apr 2023.