MANDIBLENCT01034930
Clinical Study on the Efficiency of Three Different Attachment Systems for Implant-supported Mandibular Overdenture
A study testing Insertion of dental implants in people with MANDIBLE and ATROPHYC EDENTULOUS JAW, run by Concordia Dent Srl at 1 site in Romania.
Trial summary
The aim of the investigators study is to compare, in a prospective controlled clinical trial, the Locator® System with two other types of stress-breaking retention (Retentive Anchors and Magnets) for implant supported overdenture in atrophic edentulous mandible, with the use of Straumann Dental Implant System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MANDIBLE, ATROPHYC EDENTULOUS JAW
- What is being tested?
- Insertion of dental implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteRomania
- Study dates
- Aug 2004to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complains about the stability of the existing mandibular denture satisfactory from a technical point of view.
- Acceptance of a mandibular over-denture retained by two endosseous implants.
- Patients agree to a 5-year follow-up period.
Who cannot join
- Insufficient bone volume (height and with) for inserting at least a 10 mm implant (Ø 4,1).
- Angle class II relationship.
- Physical severe consideration that will affect the minimal invasive surgical procedure or constitute a hindrance for a 5-year follow-up.
- History of radiotherapy in the head and neck region.
- History of pre-prosthetic surgery (including bone graft procedures) or previous oral implants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 5-year Prospective Randomised Clinical Study on the Efficiency of Three Different Attachment Systems as Retention for Implant-supported Mandibular Overdenture.
The aim of the investigators study is to compare, in a prospective controlled clinical trial, the Locator® System with two other types of stress-breaking retention (Retentive Anchors and Magnets) for implant supported overdenture in atrophic edentulous mandible, with the use of Straumann Dental Implant System.
Read the detailed description
The study was divided in two parts - in the first part of the study 46 fully mandibular edentulous patients will be enrolled. The patients will be recruited from the University Hospital of Dentistry and 9 other private practices in Bucharest and surrounding areas.
Selected patients will be informed about the two different treatment options, about the benefit of treatment with an overdenture retained by two endosseous implants and a written informed consent will be obtained from all participants.
Initial examination
At the beginning of the treatment for each patient will be recorded:
- The medical status.
- The dental history, oral and radiographic examination.
- The hygiene status.
- An evaluation of the existing dentures.
- The estimation of dysfunctional problems.
Treatment procedure Each patient will receive 2 screw-type Straumann (Institut Straumann AG, Basel, Switzerland) standard implants Ø4.1 mm, with SLA surface in the canine region of the mandible with an interconnecting line approaching parallelism with the terminal mandibular hinge axis. The implant lengths will be 10mm and 12mm. The choice of implant length will be dictated by the preoperative radiographic assessment of bone height in the canine region and drilling distance with the principal concern achieving primary stability.
The implants will be inserted under local anaesthesia using a surgical template derived from a tooth wax-up. The implants will be placed in a 1-stage non-submerged procedure according to a strict protocol (Weingart D and ten Bruggenkate 2000). Postoperatively, antibiotics for 5 days treatment (Amoxicillin and Clavulanate Potassium or Erytromycin - for patients alergic to Penicillin), analgesics and Clorhexidine 0,12% mouth rinse will be prescribe for 14 days. Patients will not be allowed to wear the mandibular denture during the first two weeks post-operatively.
One, two and four weeks after the surgical procedure, the patients will be recalled for follow-up visits. At the first recall visit, sutures will be removed. At the second visit the lower denture will be adjusted by selective grinding at the implant location, and Protefix® (Queisser Pharma Germany) Adhesive Cushions will be provided for patients. At all recall visits, patients will receive oral hygiene instructions.
At the third follow-up visit the manufacturing of a new maxillary denture (for the full maxillary edentulous patients) and a mandibular over-denture will be initiated.
After 6 weeks healing period implants will be loaded and the patients will be randomly assigne to one of two main groups:
- Group B of 23 patients will receive retentive anchors (Institut Straumann AG, Basel, Switzerland).
- Group M of 23 patients will receive magnets (Titanmagnetics® Institut Straumann AG, Basel, Switzerland ).
Group B will be randomly divided in two subgroups: full lower denture with two gold matrices with variable retention (four lamellae functioning like a spring - 12 patients and full lower denture with two titanium matrices with defined retention (spring with a defined extraction force of 700-1100g - B.2) - 11 patients. A new mandibular overdenture with metal reinforcement will be made.
The two groups of patients will be compared in the second part of the study with 23 patients receiving Locator system abutments (Group L) following same research protocol.
A new mandibular overdenture with metal reinforcement will be made.
The prosthetic procedure will be performed according the recommendations of the producer (Straumann Dental Implant System) for retentive anchors, magnets and Locator System by experienced prosthodontists. The occlusion will be assessed on the articulator and intra-orally to secure a balanced occlusion in centric relation without anterior tooth contact.
- Conditions
- MANDIBLE, ATROPHYC EDENTULOUS JAW
- Being tested
- Insertion of dental implants
- Keywords
- MANDIBLE, IMPLANTS, OVERDENTURE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of dental implantsProcedure or surgery
Also called Mandibular overdenture metal reinforced will be made.
Each patient will receive 2 screw-type Straumann (Institut Straumann AG, Basel, Switzerland) standard implants Ø4.1 mm, with SLA surface in the canine region of the mandible with an interconnecting line approaching parallelism with the terminal mandibular hinge axis, according to a standard surgical protocol.
| Study group | Role | What they receive |
|---|---|---|
| Retentive Anchors | Active comparator | 23 patients will receive as retention system for overdentures Retentive Anchors (Straumann). Receives: Procedure: Insertion of dental implants |
| Magnets | Active comparator | 23 patients will receive Magnets (Straumann) as retention system for overdenture. Receives: Procedure: Insertion of dental implants |
| Locator System | Active comparator | 23 patients will receive Locator System (Straumann) as retention for the mandibular overdenture. Receives: Procedure: Insertion of dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
The following parameters will be assessed for implant survival: - Gingiva-score, Plaque-score, Calculus, Bleeding-score, Probing pocket depth and Implant stability will be measured using Osstell (RFA).
Measured: 5 years
Secondary outcomes (2)
Radiographic outcome: Standardised intra-oral radiographs will be made using the long cone technique. Prosthetic maintenance and complications and soft-tissue complications of the denture bearing area will be recorded.
Measured: 5 years
Patient satisfaction will be assessed with the aid of questionnaires: initial (with the original denture), after 6 months, 1-year and 5 years. Final costs for each type of retention will be calculated according to all the procedures and complications.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startAug 2004
- Primary completionSep 2009
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for MANDIBLEStudies 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia Dent Srl
- Sponsor type
- University, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Responsible party
- Principal investigator, Corina Marilena Cristache, Concordia Dent Srl
- Investigators
- CORINA MARILENA I CRISTACHE, DMD, PhD, Principal investigator, Concordia Dent Srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034930
- Sponsor's protocol ID
- 316/03-207-507
- Status last verified
- Feb 2015
- First submitted
- 17 Dec 2009
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thomason JM, Feine J, Exley C, Moynihan P, Muller F, Naert I, Ellis JS, Barclay C, Butterworth C, Scott B, Lynch C, Stewardson D, Smith P, Welfare R, Hyde P, McAndrew R, Fenlon M, Barclay S, Barker D. Mandibular two implant-supported overdentures as the first choice standard of care for edentulous patients--the York Consensus Statement. Br Dent J. 2009 Aug 22;207(4):185-6. doi: 10.1038/sj.bdj.2009.728.
PubMed 19696851Meijer HJ, Raghoebar GM, Batenburg RH, Vissink A. Mandibular overdentures supported by two Branemark, IMZ or ITI implants: a ten-year prospective randomized study. J Clin Periodontol. 2009 Sep;36(9):799-806. doi: 10.1111/j.1600-051X.2009.01442.x. Epub 2009 Jun 26.
PubMed 19563327Meijer HJ, Raghoebar GM, Batenburg RH, Visser A, Vissink A. Mandibular overdentures supported by two or four endosseous implants: a 10-year clinical trial. Clin Oral Implants Res. 2009 Jul;20(7):722-8. doi: 10.1111/j.1600-0501.2009.01710.x. Epub 2009 Mar 27.
PubMed 19489933Naert I, Alsaadi G, van Steenberghe D, Quirynen M. A 10-year randomized clinical trial on the influence of splinted and unsplinted oral implants retaining mandibular overdentures: peri-implant outcome. Int J Oral Maxillofac Implants. 2004 Sep-Oct;19(5):695-702.
PubMed 15508985Naert I, Alsaadi G, Quirynen M. Prosthetic aspects and patient satisfaction with two-implant-retained mandibular overdentures: a 10-year randomized clinical study. Int J Prosthodont. 2004 Jul-Aug;17(4):401-10.
PubMed 15382775Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, Head T, Lund JP, MacEntee M, Mericske-Stern R, Mojon P, Morais J, Naert I, Payne AG, Penrod J, Stoker GT, Tawse-Smith A, Taylor TD, Thomason JM, Thomson WM, Wismeijer D. The McGill consensus statement on overdentures. Mandibular two-implant overdentures as first choice standard of care for edentulous patients. Montreal, Quebec, May 24-25, 2002. Int J Oral Maxillofac Implants. 2002 Jul-Aug;17(4):601-2. No abstract available.
PubMed 12182304Boerrigter EM, van Oort RP, Raghoebar GM, Stegenga B, Schoen PJ, Boering G. A controlled clinical trial of implant-retained mandibular overdentures: clinical aspects. J Oral Rehabil. 1997 Mar;24(3):182-90.
PubMed 9131473van Steenberghe D, Quirynen M, Naert I, Maffei G, Jacobs R. Marginal bone loss around implants retaining hinging mandibular overdentures, at 4-, 8- and 12-years follow-up. J Clin Periodontol. 2001 Jul;28(7):628-33. doi: 10.1034/j.1600-051x.2001.028007628.x.
PubMed 11422583Cristache CM, Muntianu LA, Burlibasa M, Didilescu AC. Five-year clinical trial using three attachment systems for implant overdentures. Clin Oral Implants Res. 2014 Feb;25(2):e171-8. doi: 10.1111/clr.12086. Epub 2012 Dec 21.
PubMed 23278517Cristache CM, Ionescu C, Cristache G, Ionescu I, Iliescu AA, Burlibasa M. A 5-year prospective randomised clinical trial on the efficiency of two different attachment systems as retention for implant-supported mandibular overdenture. Radiographic assessment, cost analysis and final evaluation of treatment's success. Metalurgia International vol. XIV (2009)Special Issue nr. 16:27-34.
Cristache CM, Ionescu C, Burlibasa M, Cristache G, Iliescu AA, Dumitriu HT. Retentive anchors versus magnets as attachment systems for mandibular overdenture. A 5-year prospective randomised clinical study.Metalurgia International vol. XIV (2009) special issue no.16: 59-64
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5-year Prospective Randomised Clinical Study on the Efficiency of Three Different Attachment Systems as Retention for Implant-supported Mandibular Overdenture.
- ClinicalTrials.gov ID
- NCT01034930
- Acronym / sponsor ID
- 316/03-207-507
- Conditions
- MANDIBLE, ATROPHYC EDENTULOUS JAW
- Keywords
- MANDIBLE, IMPLANTS, OVERDENTURE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Concordia Dent SrlUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- Aug 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Dec 2009 (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 the investigators study is to compare, in a prospective controlled clinical trial, the Locator® System with two other types of stress-breaking retention (Retentive Anchors and Magnets) for implant supported overdenture in atrophic edentulous mandible, with the use of Straumann Dental Implant System.
Detailed description
The study was divided in two parts - in the first part of the study 46 fully mandibular edentulous patients will be enrolled. The patients will be recruited from the University Hospital of Dentistry and 9 other private practices in Bucharest and surrounding areas.
Selected patients will be informed about the two different treatment options, about the benefit of treatment with an overdenture retained by two endosseous implants and a written informed consent will be obtained from all participants.
Initial examination
At the beginning of the treatment for each patient will be recorded:
- The medical status.
- The dental history, oral and radiographic examination.
- The hygiene status.
- An evaluation of the existing dentures.
- The estimation of dysfunctional problems.
Treatment procedure Each patient will receive 2 screw-type Straumann (Institut Straumann AG, Basel, Switzerland) standard implants Ø4.1 mm, with SLA surface in the canine region of the mandible with an interconnecting line approaching parallelism with the terminal mandibular hinge axis. The implant lengths will be 10mm and 12mm. The choice of implant length will be dictated by the preoperative radiographic assessment of bone height in the canine region and drilling distance with the principal concern achieving primary stability.
The implants will be inserted under local anaesthesia using a surgical template derived from a tooth wax-up. The implants will be placed in a 1-stage non-submerged procedure according to a strict protocol (Weingart D and ten Bruggenkate 2000). Postoperatively, antibiotics for 5 days treatment (Amoxicillin and Clavulanate Potassium or Erytromycin - for patients alergic to Penicillin), analgesics and Clorhexidine 0,12% mouth rinse will be prescribe for 14 days. Patients will not be allowed to wear the mandibular denture during the first two weeks post-operatively.
One, two and four weeks after the surgical procedure, the patients will be recalled for follow-up visits. At the first recall visit, sutures will be removed. At the second visit the lower denture will be adjusted by selective grinding at the implant location, and Protefix® (Queisser Pharma Germany) Adhesive Cushions will be provided for patients. At all recall visits, patients will receive oral hygiene instructions.
At the third follow-up visit the manufacturing of a new maxillary denture (for the full maxillary edentulous patients) and a mandibular over-denture will be initiated.
After 6 weeks healing period implants will be loaded and the patients will be randomly assigne to one of two main groups:
- Group B of 23 patients will receive retentive anchors (Institut Straumann AG, Basel, Switzerland).
- Group M of 23 patients will receive magnets (Titanmagnetics® Institut Straumann AG, Basel, Switzerland ).
Group B will be randomly divided in two subgroups: full lower denture with two gold matrices with variable retention (four lamellae functioning like a spring - 12 patients and full lower denture with two titanium matrices with defined retention (spring with a defined extraction force of 700-1100g - B.2) - 11 patients. A new mandibular overdenture with metal reinforcement will be made.
The two groups of patients will be compared in the second part of the study with 23 patients receiving Locator system abutments (Group L) following same research protocol.
A new mandibular overdenture with metal reinforcement will be made.
The prosthetic procedure will be performed according the recommendations of the producer (Straumann Dental Implant System) for retentive anchors, magnets and Locator System by experienced prosthodontists. The occlusion will be assessed on the articulator and intra-orally to secure a balanced occlusion in centric relation without anterior tooth contact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retentive Anchors | Active comparator | Procedure: Insertion of dental implants23 patients will receive as retention system for overdentures Retentive Anchors (Straumann). |
| Magnets | Active comparator | Procedure: Insertion of dental implants23 patients will receive Magnets (Straumann) as retention system for overdenture. |
| Locator System | Active comparator | Procedure: Insertion of dental implants23 patients will receive Locator System (Straumann) as retention for the mandibular overdenture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Complains about the stability of the existing mandibular denture satisfactory from a technical point of view.
- Acceptance of a mandibular over-denture retained by two endosseous implants.
- Patients agree to a 5-year follow-up period.
Key exclusion criteria (5 listed)
- Insufficient bone volume (height and with) for inserting at least a 10 mm implant (Ø 4,1).
- Angle class II relationship.
- Physical severe consideration that will affect the minimal invasive surgical procedure or constitute a hindrance for a 5-year follow-up.
- History of radiotherapy in the head and neck region.
- History of pre-prosthetic surgery (including bone graft procedures) or previous oral implants.
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 |
|---|---|---|
| Insertion of dental implantsAlso: Mandibular overdenture metal reinforced will be made.Each patient will receive 2 screw-type Straumann (Institut Straumann AG, Basel, Switzerland) standard implants Ø4.1 mm, with SLA surface in the canine region of the mandible with an interconnecting line approaching parallelism with the terminal mandibular hinge axis, according to a standard surgical protocol. | Procedure or surgery | Locator System, Magnets, Retentive Anchors |
Primary outcome
The following parameters will be assessed for implant survival: - Gingiva-score, Plaque-score, Calculus, Bleeding-score, Probing pocket depth and Implant stability will be measured using Osstell (RFA).
Time frame: 5 years
2 secondary outcomes
Radiographic outcome: Standardised intra-oral radiographs will be made using the long cone technique. Prosthetic maintenance and complications and soft-tissue complications of the denture bearing area will be recorded.
Time frame: 5 years
Patient satisfaction will be assessed with the aid of questionnaires: initial (with the original denture), after 6 months, 1-year and 5 years. Final costs for each type of retention will be calculated according to all the procedures and complications.
Time frame: 5 years
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 4 Feb 2015.
- Background: PubMed 19696851Thomason JM, Feine J, Exley C, Moynihan P, Muller F, Naert I, Ellis JS, Barclay C, Butterworth C, Scott B, Lynch C, Stewardson D, Smith P, Welfare R, Hyde P, McAndrew R, Fenlon M, Barclay S, Barker D. Mandibular two implant-supported overdentures as the first choice standard of care for edentulous patients--the York Consensus Statement. Br Dent J. 2009 Aug 22;207(4):185-6. doi: 10.1038/sj.bdj.2009.728.
- Background: PubMed 19563327Meijer HJ, Raghoebar GM, Batenburg RH, Vissink A. Mandibular overdentures supported by two Branemark, IMZ or ITI implants: a ten-year prospective randomized study. J Clin Periodontol. 2009 Sep;36(9):799-806. doi: 10.1111/j.1600-051X.2009.01442.x. Epub 2009 Jun 26.
- Background: PubMed 19489933Meijer HJ, Raghoebar GM, Batenburg RH, Visser A, Vissink A. Mandibular overdentures supported by two or four endosseous implants: a 10-year clinical trial. Clin Oral Implants Res. 2009 Jul;20(7):722-8. doi: 10.1111/j.1600-0501.2009.01710.x. Epub 2009 Mar 27.
- Background: PubMed 15508985Naert I, Alsaadi G, van Steenberghe D, Quirynen M. A 10-year randomized clinical trial on the influence of splinted and unsplinted oral implants retaining mandibular overdentures: peri-implant outcome. Int J Oral Maxillofac Implants. 2004 Sep-Oct;19(5):695-702.
- Background: PubMed 15382775Naert I, Alsaadi G, Quirynen M. Prosthetic aspects and patient satisfaction with two-implant-retained mandibular overdentures: a 10-year randomized clinical study. Int J Prosthodont. 2004 Jul-Aug;17(4):401-10.
- Background: PubMed 12182304Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, Head T, Lund JP, MacEntee M, Mericske-Stern R, Mojon P, Morais J, Naert I, Payne AG, Penrod J, Stoker GT, Tawse-Smith A, Taylor TD, Thomason JM, Thomson WM, Wismeijer D. The McGill consensus statement on overdentures. Mandibular two-implant overdentures as first choice standard of care for edentulous patients. Montreal, Quebec, May 24-25, 2002. Int J Oral Maxillofac Implants. 2002 Jul-Aug;17(4):601-2. No abstract available.
- Background: PubMed 9131473Boerrigter EM, van Oort RP, Raghoebar GM, Stegenga B, Schoen PJ, Boering G. A controlled clinical trial of implant-retained mandibular overdentures: clinical aspects. J Oral Rehabil. 1997 Mar;24(3):182-90.
- Background: PubMed 11422583van Steenberghe D, Quirynen M, Naert I, Maffei G, Jacobs R. Marginal bone loss around implants retaining hinging mandibular overdentures, at 4-, 8- and 12-years follow-up. J Clin Periodontol. 2001 Jul;28(7):628-33. doi: 10.1034/j.1600-051x.2001.028007628.x.
- Background: PubMed 23278517Cristache CM, Muntianu LA, Burlibasa M, Didilescu AC. Five-year clinical trial using three attachment systems for implant overdentures. Clin Oral Implants Res. 2014 Feb;25(2):e171-8. doi: 10.1111/clr.12086. Epub 2012 Dec 21.
- Results publicationCristache CM, Ionescu C, Cristache G, Ionescu I, Iliescu AA, Burlibasa M. A 5-year prospective randomised clinical trial on the efficiency of two different attachment systems as retention for implant-supported mandibular overdenture. Radiographic assessment, cost analysis and final evaluation of treatment's success. Metalurgia International vol. XIV (2009)Special Issue nr. 16:27-34.
- Results publicationCristache CM, Ionescu C, Burlibasa M, Cristache G, Iliescu AA, Dumitriu HT. Retentive anchors versus magnets as attachment systems for mandibular overdenture. A 5-year prospective randomised clinical study.Metalurgia International vol. XIV (2009) special issue no.16: 59-64
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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.
CORINA MARILENA I CRISTACHE, DMD, PhD principal investigator
Concordia Dent Srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of dental implants in people with MANDIBLE and ATROPHYC EDENTULOUS JAW, run by Concordia Dent Srl at 1 site in Romania.
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 3 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 4 Feb 2015. 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 Romania. 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?
The following parameters will be assessed for implant survival: - Gingiva-score, Plaque-score, Calculus, Bleeding-score, Probing pocket depth and Implant stability will be measured using Osstell (RFA). (time frame: 5 years). 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 NCT01034930, which also lists 11 linked publications.
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 4 Feb 2015.