EdentulismNCT06637930
Comparing Cobalt-Chromium Versus PEEK Secondary Telescopic Crowns on Implant Retained Mandibular Overdenture.
A study testing Edentulous Alveolar Ridge In Mandible in people with Edentulism, run by Amr El Sayed Khalifa at 1 site in Egypt.
Trial summary
The aim of this randomized clinical trial was to compare I- The clinical behavior of implant retained removable overdenture using telescopic retention system fabricated using CAD\CAM techniques where the effects of the different material combinations were examined in regard to: 1. Read more about this study
- Who is it for?
- Ages 52 to 64 years
- Conditions the study is for
- Edentulism
- What is being tested?
- Edentulous Alveolar Ridge In Mandible
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2022to 10 Jan 2024
- 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 52 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Completely edentulous patients
- Absence of any systematic contraindications to implant surgery,
- Presence of sufficient bone height and width to accommodate implants with length 14mmm and diameter 3.6mm.
- Inter-arch distance more than or equal 10 mm.
- Four months since the last extraction had taken place.
- No previous bone augmentation procedures.
Who cannot join
- psychological disorders prohibiting implant treatment.
- Heavy smoking (10 cigarettes/day)
- Alcohol and/or drug abuse,
- Physical disability that may interfere with the ability to perform oral hygiene.
- Patients were receiving drugs which impair healing .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluations of Implant Retained Mandibular Overdenture Using CAD\CAM Fabricated Telescopic Crown: Randomized Clinical Trial
The aim of this randomized clinical trial was to compare
I- The clinical behavior of implant retained removable overdenture using telescopic retention system fabricated using CAD\CAM techniques where the effects of the different material combinations were examined in regard to:
- Retention of the mandibular over-denture.
- Plaque accumulation, presence of calculus, bleeding tendency, health of peri-implant mucosa and probing depth.
II - The radiographic behavior regarding marginal bone level and bone density.
Read the detailed description
This study compared implant-retained telescopic mandibular overdentures reinforced with milled metal framework (Co-Cr) and milled polymer (PEEK) in terms of retention, periimplant mucosal health, and radiographic changes in twelve patients.
Initially, all patients received conventional complete dentures. A CBCT was conducted prior to the implant surgical phase using a radiographic stent. Two implants were inserted interforaminally using a flapless method. The implants were then left for three months to allow for osseointegration, and the patients were instructed to wear their complete dentures during the healing process.
Following the osseointegration period, the prosthetic phase began, with all patients obtaining primary crowns constructed from titanium alloys. The patients were then randomly divided into two groups, 6 patients in each group. Group A received a COCR framework that included secondary crowns while group B received a PEEK framework and secondary crowns.
Retention was tested for each group (baseline, 6 months, 9 months, and 12 months) using a digital force gauge. The pulling force gradually increased until the denture was dislodged. The retentive force was measured during the initial separation of the telescopic crown.
Soft tissue conditions was assessed using single coded probe for each group (baseline, 6 months, 9 months, and 12 months).Bleeding tendency on probing, plaque accumulation, calculus deposition, perimplant mucosal health were the parameters for each group evaluation.
While the radiographic assessment was performed for each group (baseline, 6months, 9 months and12 months) using digital periapical radiographs by the means of XCP instrument and digital sensor. The marginal bone level was measured by evaluating the difference of bone level at the neck of the implant. The bone density was evaluated at three areas surrounding the implants.
- Conditions
- Edentulism
- Being tested
- Edentulous Alveolar Ridge In Mandible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edentulous Alveolar Ridge In MandibleOther
implant retained mandibular overdenture using telescopic attachment system. all the patients received 2 implants at the canine region bilaterally using sterelithographic guide , then healing period for 3 months for proper osseointegration , then digital intraoral scanning was performed to detect implant position using scannable bodies , abutments which act as primary crowns were designed on cad software then milled using premilled titanium abutments.the study grouping was performed then virtual model was done for the designing of the frameworks then milled according to the grouping of the study. Try in of the frameworks was done and overdentures were inserted.
- Retention force test was done using digital force gauge.
- Probing depth using Teflon coated periodontal probe.
- Marginal bone level and bone density were measured using digital periapical x-ray
| Study group | Role | What they receive |
|---|---|---|
| Cobalt chromium(COCR) group | Experimental | The secondary crowns and the framework were fabricated using milled Cobalt chromium alloy Receives: Other: Edentulous Alveolar Ridge In Mandible |
| Polyetheretherketone(PEEK) Group | Experimental | The secondary crowns and the framework were fabricated using milled PEEK material Receives: Other: Edentulous Alveolar Ridge In Mandible |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoral retention force assessment in Newtons (N)
using force gauge at the geometric center of the overdentiure
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Mar 2022
- Primary completion30 Nov 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies 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
- Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amr El Sayed Khalifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amr El Sayed Khalifa, Minia University
- Investigators
- Emad TB Agamy, Professor of Prosthodontics, Study chair, Faculty of Dentistry, Minia university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637930
- Sponsor's protocol ID
- 528
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 16 Oct 2024
- 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluations of Implant Retained Mandibular Overdenture Using CAD\CAM Fabricated Telescopic Crown: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06637930
- Acronym / sponsor ID
- 528
- Conditions
- Edentulism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Amr El Sayed KhalifaUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 15 Oct 2024 (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 randomized clinical trial was to compare
I- The clinical behavior of implant retained removable overdenture using telescopic retention system fabricated using CAD\CAM techniques where the effects of the different material combinations were examined in regard to:
- Retention of the mandibular over-denture.
- Plaque accumulation, presence of calculus, bleeding tendency, health of peri-implant mucosa and probing depth.
II - The radiographic behavior regarding marginal bone level and bone density.
Detailed description
This study compared implant-retained telescopic mandibular overdentures reinforced with milled metal framework (Co-Cr) and milled polymer (PEEK) in terms of retention, periimplant mucosal health, and radiographic changes in twelve patients.
Initially, all patients received conventional complete dentures. A CBCT was conducted prior to the implant surgical phase using a radiographic stent. Two implants were inserted interforaminally using a flapless method. The implants were then left for three months to allow for osseointegration, and the patients were instructed to wear their complete dentures during the healing process.
Following the osseointegration period, the prosthetic phase began, with all patients obtaining primary crowns constructed from titanium alloys. The patients were then randomly divided into two groups, 6 patients in each group. Group A received a COCR framework that included secondary crowns while group B received a PEEK framework and secondary crowns.
Retention was tested for each group (baseline, 6 months, 9 months, and 12 months) using a digital force gauge. The pulling force gradually increased until the denture was dislodged. The retentive force was measured during the initial separation of the telescopic crown.
Soft tissue conditions was assessed using single coded probe for each group (baseline, 6 months, 9 months, and 12 months).Bleeding tendency on probing, plaque accumulation, calculus deposition, perimplant mucosal health were the parameters for each group evaluation.
While the radiographic assessment was performed for each group (baseline, 6months, 9 months and12 months) using digital periapical radiographs by the means of XCP instrument and digital sensor. The marginal bone level was measured by evaluating the difference of bone level at the neck of the implant. The bone density was evaluated at three areas surrounding the implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cobalt chromium(COCR) group | Experimental | Other: Edentulous Alveolar Ridge In MandibleThe secondary crowns and the framework were fabricated using milled Cobalt chromium alloy |
| Polyetheretherketone(PEEK) Group | Experimental | Other: Edentulous Alveolar Ridge In MandibleThe secondary crowns and the framework were fabricated using milled PEEK material |
Who may qualify
- Ages
- 52 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Completely edentulous patients
- Absence of any systematic contraindications to implant surgery,
- Presence of sufficient bone height and width to accommodate implants with length 14mmm and diameter 3.6mm.
- Inter-arch distance more than or equal 10 mm.
- Four months since the last extraction had taken place.
Key exclusion criteria (5 listed)
- psychological disorders prohibiting implant treatment.
- Heavy smoking (10 cigarettes/day)
- Alcohol and/or drug abuse,
- Physical disability that may interfere with the ability to perform oral hygiene.
- Patients were receiving drugs which impair healing .
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 |
|---|---|---|
| Edentulous Alveolar Ridge In Mandibleimplant retained mandibular overdenture using telescopic attachment system. all the patients received 2 implants at the canine region bilaterally using sterelithographic guide , then healing period for 3 months for proper osseointegration , then digital intraoral scanning was performed to detect implant position using scannable bodies , abutments which act as primary crowns were designed on cad software then milled using premilled titanium abutments.the study grouping was performed then virtual model was done for the designing of the frameworks then milled according to the grouping of the study. Try in of the frameworks was done and overdentures were inserted. * Retention force test was done using digital force gauge. * Probing depth using Teflon coated periodontal probe. * Marginal bone level and bone density were measured using digital periapical x-ray | Other | Cobalt chromium(COCR) group, Polyetheretherketone(PEEK) Group |
Primary outcome
intraoral retention force assessment in Newtons (N)
Time frame: 1 year follow up
using force gauge at the geometric center of the overdentiure
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 Oct 2024.
- 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.
Emad TB Agamy, Professor of Prosthodontics study chair
Faculty of Dentistry, Minia 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 Edentulous Alveolar Ridge In Mandible in people with Edentulism, run by Amr El Sayed Khalifa 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 6 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 16 Oct 2024. 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?
intraoral retention force assessment in Newtons (N) (time frame: 1 year follow up). 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 Oct 2024.