Denture, Partial, RemovablePhase 4NCT00176215
Clinical Comparison of RPDs Retained by Conical and Galvanoformed Double Crowns.
A Phase 4 study testing survival failure of more than 20 % in people with Denture, Partial, Removable and Dental Prosthesis Retention, run by Heidelberg University at 2 sites in Germany.
Trial summary
The aim of this prospective clinical trial was to investigate the clinical performance and complication rate of RPDs (Removable partial dentures) retained on conventional conical double crowns in comparison to galvanoformed telscopic double crowns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Denture, Partial, Removable, Dental Prosthesis Retention, Oral Health
- What is being tested?
- survival failure of more than 20 %
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesGermany
- Study dates
- May 2003to not given
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Indication for RPDs retained by double crowns; 2 to 6 Abutment teeth;
Who cannot join
- limited contractual capability and absence of consent of the patient
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
University of Heidelberg
Heidelberg, Baden_Württemberg, 69120
About this study
The aim of this prospective clinical trial was to investigate the clinical performance and complication rate of RPDs (Removable partial dentures) retained on conventional conical double crowns in comparison to galvanoformed telscopic double crowns. Additionally the OHIP (Oral Health related Qualitiy of Life)and the abrasion of the teeth were investigated.
- Being tested
- survival failure of more than 20 %
- Medical subject headings
- Tooth Abrasion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survival failure of more than 20 %Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture, Partial, RemovableStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Christiane Grossmann, DDS, Study chair, Heidelberg UniversityFranziska Lehmann, DDS, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176215
- Sponsor's protocol ID
- CG-FL-1
- Status last verified
- Jul 2005
- First submitted
- 13 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of RPDs Retained by Conical and Galvanoformed Double Crowns.
- ClinicalTrials.gov ID
- NCT00176215
- Acronym / sponsor ID
- CG-FL-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- May 2003
- First posted
- 15 Sep 2005 (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 prospective clinical trial was to investigate the clinical performance and complication rate of RPDs (Removable partial dentures) retained on conventional conical double crowns in comparison to galvanoformed telscopic double crowns. Additionally the OHIP (Oral Health related Qualitiy of Life)and the abrasion of the teeth were investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for RPDs retained by double crowns; 2 to 6 Abutment teeth;
Key exclusion criteria (1 listed)
- limited contractual capability and absence of consent of the patient
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 |
|---|---|---|
| survival failure of more than 20 % | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Christiane Grossmann, DDS study chair
Heidelberg University
Franziska Lehmann, DDS principal investigator
Heidelberg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing survival failure of more than 20 % in people with Denture, Partial, Removable and Dental Prosthesis Retention, run by Heidelberg University at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 15 Sep 2005.