Mouth, EdentulousGCNCT02551146
Influence of Implants and Locators for Improved Retention
A study testing A Locator with retention elements and B Locator without retention elements in people with Mouth, Edentulous, run by Philipps University Marburg at 1 site in Germany.
Trial summary
The aim of this study is to assess the influence of this particular treatment method on the patients' quality of life and masticatory function. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Mouth, Edentulous
- What is being tested?
- A Locator with retention elements and B Locator without retention elements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- 7 Sep 2015to 17 May 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 45-80 years (male or female)
- sufficient full dentures in the mandible
- must be able to clean their teeth on their own
- edentulous mandible with interforaminal adequate bone for insertion of implants
- implantation sites free of infections and root fragments
- no need for treatment of the maxillary teeth
- Written Informed Consent
Who cannot join
- systemic diseases
- mental disability that may affect the participant's ability to properly follow study instructions
- oral mucosal diseases
- long-term medication with steroids, bisphosphonates
- known allergic reactions to dental materials
- malignant tumor in the head and neck area
- requirement of any concurrent radiotherapy or chemotherapy or any radiotherapy or chemotherapy within the last 10 years pregnancy or breastfeeding at study entry
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine
Marburg, 35033
About this study
Official title: Influence of Implants and Locators for Improved Retention of Mandibular Full Dentures on Patient's Quality of Life and Oral Function. A Controlled, Randomized and Prospective Study
The aim of this study is to assess the influence of this particular treatment method on the patients' quality of life and masticatory function.
Read the detailed description
For this prospective randomized controlled clinical trial patients with edentulous mandibles and tissue supported (full) dentures were treated with 2 dental implants and locators in order to improve prosthesis stability.
The LOCATOR System is comprised of three parts: The LOCATOR implant attachment (LOCATOR abutment), the LOCATOR Male and the LOCATOR Denture Cap. The abutment is inserted directly into the implant using a torque wrench, while the Denture Cap is placed into the base of the overdenture for polymerization using acrylic resin. Custom retention is achieved via LOCATOR Males - small color-coded (according to retention force) plastic inserts - which can be exchanged as needed.
- Conditions
- Mouth, Edentulous
- Being tested
- A Locator with retention elements, B Locator without retention elements
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Locator with retention elementsDevice
Insertion of GC Pilier locator abutments with retention elements
B Locator without retention elementsDevice
Insertion of GC Pilier locator abutments without retention elements
| Study group | Role | What they receive |
|---|---|---|
| A Locator with retention elements | Experimental | GC Pilier Locator abutment with retention elements:
For patients in the experimental group (arm A) the connection of the full dentures to the implants will be achieved by fitting the dentures with GC Pilier Locator abutments with retention elements. Receives: Device: A Locator with retention elements |
| B Locator without retention elements | Active comparator | GC Pilier Locator abutment without retention elements:
For patients with the active comparator (arm B) the full dentures will get Pilier Locator abutments without retention elements and thus no connection to the implants. Receives: Device: B Locator without retention elements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (OHIP-G-49)
The oral health-related quality of life is assessed by the German version of the Oral Health Impact Profile questionnaire (OHIP-G-49, Locker et al 1993)
Measured: 3 months after randomization
Secondary outcomes (8)
masticatory function
Video documentation of chewing a defined bolus. After chewing a defined bolus for 10 seconds comparison of reduction ratio of the bolus is documented by photography and the change from baseline will be documented.
Measured: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Plaque index
The Plaque index (Silness and Loe 1964) will be assessed and the change from baseline will be documented.
Measured: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Probing pocket depth
The Probing pocket depth with bleeding on probing (6 sites of every tooth and implant) will be assessed and the change from baseline will be documented.
Measured: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Gingival index
The Gingival index (Loe and Silness 1963) will be assessed and the change from baseline will be documented.
Measured: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Gingival recessions
The Gingival recessions at teeth will be assessed and the change from baseline will be documented.
Measured: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Mucosal recessions
The mucosal recessions at implants will be assessed and the change from baseline will be documented.
Measured: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
width of keratinized gingiva/mucosa
The width of keratinized gingiva/mucosa will be assessed and the change from baseline will be documented.
Measured: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
intraoral photo-documentation
A photo-documentation (intraoral) will be done to assess the changes from baseline.
Measured: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start7 Sep 2015
- Primary completion17 May 2018
- Study completion17 May 2018
Why it stopped: Difficulties concerning the recruitment of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mouth, EdentulousStudies 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
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reiner Mengel, Professor MD, Principal investigator, Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551146
- Sponsor's protocol ID
- KKS-217
- Acronym
- GC
- Status last verified
- Dec 2022
- First submitted
- 3 Sep 2015
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Assuncao WG, Barao VA, Delben JA, Gomes EA, Tabata LF. A comparison of patient satisfaction between treatment with conventional complete dentures and overdentures in the elderly: a literature review. Gerodontology. 2010 Jun;27(2):154-62. doi: 10.1111/j.1741-2358.2009.00299.x. Epub 2009 May 6.
PubMed 19467020
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Implants and Locators for Improved Retention of Mandibular Full Dentures on Patient's Quality of Life and Oral Function. A Controlled, Randomized and Prospective Study
- ClinicalTrials.gov ID
- NCT02551146
- Acronym / sponsor ID
- GC / KKS-217
- Conditions
- Mouth, Edentulous
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties concerning the recruitment of participants
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 7 Sep 2015 (actual)
- Primary completion
- 17 May 2018 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 16 Sep 2015 (estimated)
- 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 is to assess the influence of this particular treatment method on the patients' quality of life and masticatory function.
Detailed description
For this prospective randomized controlled clinical trial patients with edentulous mandibles and tissue supported (full) dentures were treated with 2 dental implants and locators in order to improve prosthesis stability.
The LOCATOR System is comprised of three parts: The LOCATOR implant attachment (LOCATOR abutment), the LOCATOR Male and the LOCATOR Denture Cap. The abutment is inserted directly into the implant using a torque wrench, while the Denture Cap is placed into the base of the overdenture for polymerization using acrylic resin. Custom retention is achieved via LOCATOR Males - small color-coded (according to retention force) plastic inserts - which can be exchanged as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Locator with retention elements | Experimental | Device: A Locator with retention elementsGC Pilier Locator abutment with retention elements: For patients in the experimental group (arm A) the connection of the full dentures to the implants will be achieved by fitting the dentures with GC Pilier Locator abutments with retention elements. |
| B Locator without retention elements | Active comparator | Device: B Locator without retention elementsGC Pilier Locator abutment without retention elements: For patients with the active comparator (arm B) the full dentures will get Pilier Locator abutments without retention elements and thus no connection to the implants. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 45-80 years (male or female)
- sufficient full dentures in the mandible
- must be able to clean their teeth on their own
- edentulous mandible with interforaminal adequate bone for insertion of implants
- implantation sites free of infections and root fragments
Key exclusion criteria (7 listed)
- systemic diseases
- mental disability that may affect the participant's ability to properly follow study instructions
- oral mucosal diseases
- long-term medication with steroids, bisphosphonates
- known allergic reactions to dental materials
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 |
|---|---|---|
| A Locator with retention elementsInsertion of GC Pilier locator abutments with retention elements | Device | A Locator with retention elements |
| B Locator without retention elementsInsertion of GC Pilier locator abutments without retention elements | Device | B Locator without retention elements |
Primary outcome
Quality of life (OHIP-G-49)
Time frame: 3 months after randomization
The oral health-related quality of life is assessed by the German version of the Oral Health Impact Profile questionnaire (OHIP-G-49, Locker et al 1993)
8 secondary outcomes
masticatory function
Time frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Plaque index
Time frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Probing pocket depth
Time frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Gingival index
Time frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Gingival recessions
Time frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Mucosal recessions
Time frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
width of keratinized gingiva/mucosa
Time frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
intraoral photo-documentation
Time frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Results and safety
The study was stopped early (reason given: Difficulties concerning the recruitment of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Background: PubMed 19467020Assuncao WG, Barao VA, Delben JA, Gomes EA, Tabata LF. A comparison of patient satisfaction between treatment with conventional complete dentures and overdentures in the elderly: a literature review. Gerodontology. 2010 Jun;27(2):154-62. doi: 10.1111/j.1741-2358.2009.00299.x. Epub 2009 May 6.
- 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.
Reiner Mengel, Professor MD principal investigator
Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Locator with retention elements and B Locator without retention elements in people with Mouth, Edentulous, run by Philipps University Marburg at 1 site in Germany.
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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 22 Dec 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 Germany. 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 was stopped early (reason given: Difficulties concerning the recruitment of participants). Results are not available in the source record.
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?
Quality of life (OHIP-G-49) (time frame: 3 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02551146, which also lists 1 linked publication.
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 22 Dec 2022.