Dental ImplantADLCvsLOCNCT04544839
Clinical Evaluation of Two Different Attachment System
A study testing ADLC attachment system with PEEK inserts in people with Dental Implant, run by University of Zurich at 1 site in India.
Trial summary
Edentulous patients commonly experience a deterioration in the quality of life; both in terms of oral and general health. Studies demonstrated that conventional dentures do not adequately restore masticatory function nor quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- ADLC attachment system with PEEK inserts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndia
- Study dates
- 2 Nov 2020to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fully edentulous patients encountering problems (functional, aesthetics) with existing dentures in the upper and lower jaw or patients seeking for implant-supported prostheses
- Adequate bone in the anterior mandible for the placement of implants (Regular diameter implant with a minimal length of 10mm) in the canine region
- Written informed consent
- Ability to understand the procedure and to answer a questionnaire.
Who cannot join
- Impaired cognitive function and/or manual dexterity
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Unable to attend follow-up examinations
- Known or suspected non-compliance, drug or alcohol abuse
- Presence of any uncontrolled systematic disease that could compromise implant surgery and implant long-term performance
- History of radiotherapy in the head and neck region
Show all 11Show fewer
- Heavy smoker (>10 cig. /day
- Any potential allergies or hypersensitivity to chemical ingredients of material used
- Bruxism
- Presence of bone metabolic disorders (e.g. osteoporosis)
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
M.A.Rangoonwala College of Dental Sciences & Research Center
Pune, 411001
About this study
Official title: Evaluation of Patient Reported Outcome Measures and Clinical Performance of Implant Supported Overdentures With Two Different Attachment Systems: A Randomized Cross Over Clinical Study
Edentulous patients commonly experience a deterioration in the quality of life; both in terms of oral and general health. Studies demonstrated that conventional dentures do not adequately restore masticatory function nor quality of life. In contrast, implant-supported overdentures are considered the standard of care for edentulous patients as they offer a more stable prosthesis that ultimately results in improved oral function and patient satisfaction.
Precision attachments such as studs, magnets, telescopic crowns or a bars are commonly used for implant supported overdentures. Implant overdentures supported by stud attachments gained popularity for the rehabilitation of edentulous patients as they are self-aligning, offer dual retention and compensate for divergence between implants up to angles of 40 degrees.
Read more
However, it has been documented that the stud attachment system (Locators) requires a high frequency of maintenance, particularly with regard to the replacement of the matrix.
In order to overcome some of these limitations of existing attachment systems, a newer system was developed consisting of a matrix made of polyetheretherketone (PEEK) instead of a polymeric material. This system has an amorphous diamond like carbon-based abutment coating (ADLC) and it was claimed to be more resistant to wear.
Clinically and in vitro, no comparative studies have been performed addressing wear and retention of the traditional stud attachment and the newer ADLC attachment.
Thus, the aim of the present study is to clinically and in vitro evaluate the ADLC and study attachment system.
- Conditions
- Dental Implant
- Being tested
- ADLC attachment system with PEEK inserts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADLC attachment system with PEEK insertsDevice
Also called NOVALOC
Each patient will receive 2 implants in the canine region using a guided-surgery protocol and a pre-prepared surgical stent. A healing abutment of an adequate size will be placed on the implant for transmucosal healing. The flaps will be subsequently sutured around the healing abutments. Patients' existing prostheses will be adjusted. Suture removal will be performed one week post implant placement.
Three months later, implant level impressions will be made using the open tray technique. Each patient will be then be randomized using eCRF (electronic Case Report Form) to either ADLC group or LOC group. A final cast of the patients will be obtained and the attachments will be installed using an in-direct technique by a calibrated prosthodontists.
| Study group | Role | What they receive |
|---|---|---|
| ADLC attachment in first phase | Experimental | Each patient will receive 2 implants in the canine region. Three months later, each patient will be randomized and half of the patients will receive first the ADLC (test) device (first phase). In the second phase of the crossover trial (6 months after the start of the first phase), the attachments will be replaced. Patients previously allocated to the ADLC group will receive the LOC attachments. Receives: Device: ADLC attachment system with PEEK inserts |
| LOC attachment in first phase | Active comparator | Each patient will receive 2 implants in the canine region. Three months later, each patient will be randomized and half of the patients will receive first the LOC (control) device (first phase). In the second phase of the crossover trial (6 months after the start of the first phase), the attachments will be replaced. Patients previously allocated to the LOC group will receive the ADLC attachments. Receives: Device: ADLC attachment system with PEEK inserts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcome measure
Mean VAS scores (visual analogue scale (0-100)) related to patient overall satisfaction for the ADLC and the LOC (Locator) attachment system provided by the patients
Measured: After a functional period of 6 months
Secondary outcomes (7)
Patient-Reported Outcome Measures (PROMs): VAS
VAS scores (visual analogue scale (0-100)) based questionnaires about retention, stability of the prosthesis, maintenance of oral hygiene, ability to speak, comfort and aesthetics will be evaluated at screening
Measured: 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems
Patient-Reported Outcome Measures (PROMs): OHIP-14
OHIP-14 (Oral Health Impact Profile) will be evaluated at screening (Questionnaire)
Measured: 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems
Patient-Reported Outcome Measures (PROMs): Costs
Costs (INR) related to the entire treatment including additional appointments scheduled for repair and/or replacement of prostheses/matrix/matrix components
Measured: 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems
Technical outcomes:
Questionnaire (Wear of the polymeric and PEEK inserts, Deterioration of the PEEK and polymeric inserts, Initial and final retention of the two attachment systems)
Measured: 6 months after the first and the second evaluation period, respectively
Clinical outcomes: PCR
Plaque control record (PCR) (Questionnaire: 0/1)
Measured: after a functional period of 6 months for each attachment system; and1, 3 and 5 years after the evaluation period of the second attachment systems
Clinical outcomes: BOP
Bleeding on probing (BOP) (Questionnaire: 0/1)
Measured: after a functional period of 6 months for each attachment system; and1, 3 and 5 years after the evaluation period of the second attachment systems
Clinical outcomes: PD
Probing depth (PD) (mm)
Measured: after a functional period of 6 months for each attachment system; and1, 3 and 5 years after the evaluation period of the second attachment systems
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 start2 Nov 2020
- Primary completionDec 2022 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohit Kheur, Prof., Principal investigator, M.A.Rangoonwala College of Dental Sciences & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544839
- Sponsor's protocol ID
- MCES/EC/613/2020
- Acronym
- ADLCvsLOC
- Status last verified
- Jun 2022
- First submitted
- 26 Aug 2020
- Last updated
- 24 Jun 2022
- 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 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Reported Outcome Measures and Clinical Performance of Implant Supported Overdentures With Two Different Attachment Systems: A Randomized Cross Over Clinical Study
- ClinicalTrials.gov ID
- NCT04544839
- Acronym / sponsor ID
- ADLCvsLOC / MCES/EC/613/2020
- Conditions
- Dental Implant
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2028 (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.
Edentulous patients commonly experience a deterioration in the quality of life; both in terms of oral and general health. Studies demonstrated that conventional dentures do not adequately restore masticatory function nor quality of life. In contrast, implant-supported overdentures are considered the standard of care for edentulous patients as they offer a more stable prosthesis that ultimately results in improved oral function and patient satisfaction.
Precision attachments such as studs, magnets, telescopic crowns or a bars are commonly used for implant supported overdentures. Implant overdentures supported by stud attachments gained popularity for the rehabilitation of edentulous patients as they are self-aligning, offer dual retention and compensate for divergence between implants up to angles of 40 degrees.
However, it has been documented that the stud attachment system (Locators) requires a high frequency of maintenance, particularly with regard to the replacement of the matrix.
In order to overcome some of these limitations of existing attachment systems, a newer system was developed consisting of a matrix made of polyetheretherketone (PEEK) instead of a polymeric material. This system has an amorphous diamond like carbon-based abutment coating (ADLC) and it was claimed to be more resistant to wear.
Clinically and in vitro, no comparative studies have been performed addressing wear and retention of the traditional stud attachment and the newer ADLC attachment.
Thus, the aim of the present study is to clinically and in vitro evaluate the ADLC and study attachment system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADLC attachment in first phase | Experimental | Device: ADLC attachment system with PEEK insertsEach patient will receive 2 implants in the canine region. Three months later, each patient will be randomized and half of the patients will receive first the ADLC (test) device (first phase). In the second phase of the crossover trial (6 months after the start of the first phase), the attachments will be replaced. Patients previously allocated to the ADLC group will receive the LOC attachments. |
| LOC attachment in first phase | Active comparator | Device: ADLC attachment system with PEEK insertsEach patient will receive 2 implants in the canine region. Three months later, each patient will be randomized and half of the patients will receive first the LOC (control) device (first phase). In the second phase of the crossover trial (6 months after the start of the first phase), the attachments will be replaced. Patients previously allocated to the LOC group will receive the ADLC attachments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fully edentulous patients encountering problems (functional, aesthetics) with existing dentures in the upper and lower jaw or patients seeking for implant-supported prostheses
- Adequate bone in the anterior mandible for the placement of implants (Regular diameter implant with a minimal length of 10mm) in the canine region
- Written informed consent
- Ability to understand the procedure and to answer a questionnaire.
Key exclusion criteria (11 listed)
- Impaired cognitive function and/or manual dexterity
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Unable to attend follow-up examinations
- Known or suspected non-compliance, drug or alcohol abuse
- Presence of any uncontrolled systematic disease that could compromise implant surgery and implant long-term performance
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 |
|---|---|---|
| ADLC attachment system with PEEK insertsAlso: NOVALOCEach patient will receive 2 implants in the canine region using a guided-surgery protocol and a pre-prepared surgical stent. A healing abutment of an adequate size will be placed on the implant for transmucosal healing. The flaps will be subsequently sutured around the healing abutments. Patients' existing prostheses will be adjusted. Suture removal will be performed one week post implant placement. Three months later, implant level impressions will be made using the open tray technique. Each patient will be then be randomized using eCRF (electronic Case Report Form) to either ADLC group or LOC group. A final cast of the patients will be obtained and the attachments will be installed using an in-direct technique by a calibrated prosthodontists. | Device | ADLC attachment in first phase, LOC attachment in first phase |
Primary outcome
Patient reported outcome measure
Time frame: After a functional period of 6 months
Mean VAS scores (visual analogue scale (0-100)) related to patient overall satisfaction for the ADLC and the LOC (Locator) attachment system provided by the patients
7 secondary outcomes
Patient-Reported Outcome Measures (PROMs): VAS
Time frame: 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems
Patient-Reported Outcome Measures (PROMs): OHIP-14
Time frame: 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems
Patient-Reported Outcome Measures (PROMs): Costs
Time frame: 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems
Technical outcomes:
Time frame: 6 months after the first and the second evaluation period, respectively
Clinical outcomes: PCR
Time frame: after a functional period of 6 months for each attachment system; and1, 3 and 5 years after the evaluation period of the second attachment systems
Clinical outcomes: BOP
Time frame: after a functional period of 6 months for each attachment system; and1, 3 and 5 years after the evaluation period of the second attachment systems
Clinical outcomes: PD
Time frame: after a functional period of 6 months for each attachment system; and1, 3 and 5 years after the evaluation period of the second attachment systems
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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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.
Mohit Kheur, Prof. principal investigator
M.A.Rangoonwala College of Dental Sciences & Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADLC attachment system with PEEK inserts in people with Dental Implant, run by University of Zurich at 1 site in India.
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 4 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 24 Jun 2022. 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 India. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient reported outcome measure (time frame: After a functional period of 6 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 24 Jun 2022.