Severe Atrophy of the Edentulous MandibleROM-OHIP-EDNCT01392456
Validation and Cross-Cultural Adaptation of the Romanian Version of Oral Health Impact Profile in Edentulous Adults
A study testing Insertion of two screw type dental implants in people with Severe Atrophy of the Edentulous Mandible, run by Concordia Dent Srl at 1 site in Romania.
Trial summary
The aim of the study is: 1. To validate the Romanian translation of OHIP-EDENT (Oral Health Impact Profile in Edentulous Adults), the short form of OHIP (Oral Health Impact Profile) developed by Allen and Locker for edentulous adults. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Severe Atrophy of the Edentulous Mandible
- What is being tested?
- Insertion of two screw type 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
- Jun 2004to Feb 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully mandibular edentulous patients
- 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: Patient Satisfaction With the Use of Three Different Systems as Retention for Implant Supported Mandibular Overdentures.
The aim of the study is:
- To validate the Romanian translation of OHIP-EDENT (Oral Health Impact Profile in Edentulous Adults), the short form of OHIP (Oral Health Impact Profile) developed by Allen and Locker for edentulous adults. The OHIP questionnaire is an efficient instrument for assessment of OHRQoL - Oral Health-Related Quality of Life.
- To compare satisfaction of 69 fully mandibular edentulous patients rehabilitated with implant-supported overdentures with three different types of retention: Retentive Anchors, Magnets, Locator.
Read the detailed description
Fully edentulism can substantially affect oral and general health as well overall quality of life and inappropriate treatment using classical prosthesis may impaired buccal function, increase alveolar bone loss and also is often unsatisfactory for most patients.
Implant-retained dentures provide successful long-term outcomes, particularly when used to rehabilitate the edentulous mandible (Assad et al. 2004; Chan et al. 1995; Davis et al. 1999). Results achievable with such prostheses are well known: the degree of stability, chewing efficiency, and ultimately patient satisfaction exceeds the benefits obtained with conventional denture treatment.
However few studies have addressed the perception of treatments outcomes by patients and is critically important to determine whether there are meaningful differences based on the type of retention used (Retentive Anchors, Magnets, Locator).
OHIP-EDENT (Oral Health Impact Profile in Edentulous Adults), the short form (19 items) of OHIP (Oral Health Impact Profile) detects the impact of oral health in the quality of life of patients who wear total prosthesis and include questions addressing masticatory capacity, pleasure of eating, level of comfort and relationship problems.
This questionnaire is validated in several languages but still not available in Romanian.
Material and methods
- Linguistic and cultural adaptation: Because the OHIP EDENT had not previously been used in Romania, it was piloted to assess the face and content validity within the target population. The OHIP EDENT was linguistically and culturally adapted to our setting by using the back translation technique (according to guidelines provided by Beaton et al. 2000) in order to maintain cross-cultural equivalence. In this procedure, translations were independently made by two bilingual persons, who then discussed and produced a consensus Romanian version (T1 and T2 produced T12), which was translated back into English by two professional English translator (one native English) who had never seen the original version (BT1 and BT2 versions). The conceptual equivalence between the original instruments and the back-translated versions was supported by an expert committee (formed by 3 researchers: methodologist, two experts on quality of life studies, and the four translators). The definitive Romanian version was produced after the face and content validity results in the pilot study had been approved by this committee.
- Pilot study: Ethical approval and specific written consent were obtained from the relevant authorities before the pilot study were started. The pilot study was conducted in a convenience sample (n=35) obtained from mandibular edentulous patients who came to the Dental School, University of Medicine and Pharmacy Bucharest, Romania and Concordia Dent Clinic, Bucharest. Participants were clinically examined according to the WHO (World Health Organization) methodology and completed the pilot OHIP EDENT. The comprehensiveness of the instrument was tested by asking about difficulties in understanding items or frequencies, in order to optimize the face and content validity before the main study. Reproducibility was evaluated by measuring test - retest reliability. Test-retest reliability was calculated using intraclass correlation coefficient (ICC). The sample of 35 respondents fully edentulous was interviewed two weeks after the first interview.
- Main Study:
Patient satisfaction was assessed with the aid of OHIP-EDENT questionnaire validated initial (with the original denture), after 6 months and at 1, 3, 5 years post overdenture insertion.
- Being tested
- Insertion of two screw type dental implants
- Keywords
- OHIP-EDENT, VALIDATION, OVERDENTURE, ROMANIAN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of two screw type dental implantsProcedure or surgery
Also called Straumann (Institute Straumann AG, Basel, Switzerland)
Each patient (of the 69 recruited) will receive 2 screw-type Straumann (Institute 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, in a 1-stage non-submerged procedure according to a strict protocol (Weingart D and ten Bruggenkate 2000).
| Study group | Role | What they receive |
|---|---|---|
| Retentive Anchor Group | Active comparator | 23 fully edentulous patients will receive Retentive Anchors (Institute Straumann AG, Basel Switzerland)as retention system for the two implant overdenture. Receives: Procedure: Insertion of two screw type dental implants |
| Magnet Group | Active comparator | 23 fully edentulous patients will receive Magnets (Institute Straumann AG, Basel Switzerland)as retention system for the two implant overdenture. Receives: Procedure: Insertion of two screw type dental implants |
| Locator Group | Active comparator | 23 fully edentulous patients will receive Locator (Institute Straumann AG, Basel Switzerland)as retention system for the two implant overdenture. Receives: Procedure: Insertion of two screw type dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
OHIP-EDENT linguistic and cultural adaptation in Romanian
Steps for validation:
- linguistic and cultural adaptation of the original instrument to Romanian;
- pilot study to assess face and content validity;
- main study to assess the reliability and construct validity. OHIP-EDENT questionnaire includes 19-items addressing masticatory capacity, pleasure of eating, level of comfort, and relationship among others while wearing the prosthesis and detects the impact of oral health in the quality of life of edentulous adults wearing total prosthesis. Response categories:4=very often; 3=fairly often; 2=occasionally; 1=hardly ever; 0=never/don't know.
Measured: Two-weeks
Secondary outcomes (1)
Evaluation of patient satisfaction with the use of three different systems as retention for implant supported mandibular overdentures.
Patient satisfaction is assessed with the use of OHIP-EDENT questionnaire validated in Romanian language.
The questionnaire is administrated initial (before surgery for assessing patient satisfaction with the original denture), after 6 months of implant over-denture insertion (T) and at 1,3 and 5-year follow-up (T1, T3, T5).
The means scores will be calculated. Lower scores represents a good perception of the oral conditions, good satisfaction level and good masticatory capacity.
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 posted12 Jul 2011 (estimated)
- Study startJun 2004
- Primary completionSep 2010
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Severe Atrophy of the Edentulous 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 CLINIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392456
- Sponsor's protocol ID
- 507-207
- Other IDs
- 316/03 & 507-207
- Acronym
- ROM-OHIP-ED
- Status last verified
- Feb 2015
- First submitted
- 11 Jul 2011
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Zani SR, Rivaldo EG, Frasca LC, Caye LF. Oral health impact profile and prosthetic condition in edentulous patients rehabilitated with implant-supported overdentures and fixed prostheses. J Oral Sci. 2009 Dec;51(4):535-43. doi: 10.2334/josnusd.51.535.
PubMed 20032605Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PubMed 11124735Assad AS, Abd El-Dayem MA, Badawy MM. Comparison between mainly mucosa-supported and combined mucosa-implant-supported mandibular overdentures. Implant Dent. 2004 Dec;13(4):386-94. doi: 10.1097/01.id.0000144512.43654.08.
PubMed 15592001Weingart D, ten Bruggenkate CM. Treatment of fully edentulous patients with ITI implants. Clin Oral Implants Res. 2000;11 Suppl 1:69-82. doi: 10.1034/j.1600-0501.2000.011s1069.x.
PubMed 11168258Chan MF, Johnston C, Howell RA, Cawood JI. Prosthetic management of the atrophic mandible using endosseous implants and overdentures: a six year review. Br Dent J. 1995 Nov 11;179(9):329-37. doi: 10.1038/sj.bdj.4808917.
PubMed 7495628Davis DM, Packer ME. Mandibular overdentures stabilized by Astra Tech implants with either ball attachments or magnets: 5-year results. Int J Prosthodont. 1999 May-Jun;12(3):222-9.
PubMed 10635189Naert 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 15382775
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
- Patient Satisfaction With the Use of Three Different Systems as Retention for Implant Supported Mandibular Overdentures.
- ClinicalTrials.gov ID
- NCT01392456
- Acronym / sponsor ID
- ROM-OHIP-ED / 507-207
- Keywords
- OHIP-EDENT, VALIDATION, OVERDENTURE, ROMANIAN
- 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
- Jun 2004
- Primary completion
- Sep 2010 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Jul 2011 (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 study is:
- To validate the Romanian translation of OHIP-EDENT (Oral Health Impact Profile in Edentulous Adults), the short form of OHIP (Oral Health Impact Profile) developed by Allen and Locker for edentulous adults. The OHIP questionnaire is an efficient instrument for assessment of OHRQoL - Oral Health-Related Quality of Life.
- To compare satisfaction of 69 fully mandibular edentulous patients rehabilitated with implant-supported overdentures with three different types of retention: Retentive Anchors, Magnets, Locator.
Detailed description
Fully edentulism can substantially affect oral and general health as well overall quality of life and inappropriate treatment using classical prosthesis may impaired buccal function, increase alveolar bone loss and also is often unsatisfactory for most patients.
Implant-retained dentures provide successful long-term outcomes, particularly when used to rehabilitate the edentulous mandible (Assad et al. 2004; Chan et al. 1995; Davis et al. 1999). Results achievable with such prostheses are well known: the degree of stability, chewing efficiency, and ultimately patient satisfaction exceeds the benefits obtained with conventional denture treatment.
However few studies have addressed the perception of treatments outcomes by patients and is critically important to determine whether there are meaningful differences based on the type of retention used (Retentive Anchors, Magnets, Locator).
OHIP-EDENT (Oral Health Impact Profile in Edentulous Adults), the short form (19 items) of OHIP (Oral Health Impact Profile) detects the impact of oral health in the quality of life of patients who wear total prosthesis and include questions addressing masticatory capacity, pleasure of eating, level of comfort and relationship problems.
This questionnaire is validated in several languages but still not available in Romanian.
Material and methods
- Linguistic and cultural adaptation: Because the OHIP EDENT had not previously been used in Romania, it was piloted to assess the face and content validity within the target population. The OHIP EDENT was linguistically and culturally adapted to our setting by using the back translation technique (according to guidelines provided by Beaton et al. 2000) in order to maintain cross-cultural equivalence. In this procedure, translations were independently made by two bilingual persons, who then discussed and produced a consensus Romanian version (T1 and T2 produced T12), which was translated back into English by two professional English translator (one native English) who had never seen the original version (BT1 and BT2 versions). The conceptual equivalence between the original instruments and the back-translated versions was supported by an expert committee (formed by 3 researchers: methodologist, two experts on quality of life studies, and the four translators). The definitive Romanian version was produced after the face and content validity results in the pilot study had been approved by this committee.
- Pilot study: Ethical approval and specific written consent were obtained from the relevant authorities before the pilot study were started. The pilot study was conducted in a convenience sample (n=35) obtained from mandibular edentulous patients who came to the Dental School, University of Medicine and Pharmacy Bucharest, Romania and Concordia Dent Clinic, Bucharest. Participants were clinically examined according to the WHO (World Health Organization) methodology and completed the pilot OHIP EDENT. The comprehensiveness of the instrument was tested by asking about difficulties in understanding items or frequencies, in order to optimize the face and content validity before the main study. Reproducibility was evaluated by measuring test - retest reliability. Test-retest reliability was calculated using intraclass correlation coefficient (ICC). The sample of 35 respondents fully edentulous was interviewed two weeks after the first interview.
- Main Study:
Patient satisfaction was assessed with the aid of OHIP-EDENT questionnaire validated initial (with the original denture), after 6 months and at 1, 3, 5 years post overdenture insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retentive Anchor Group | Active comparator | Procedure: Insertion of two screw type dental implants23 fully edentulous patients will receive Retentive Anchors (Institute Straumann AG, Basel Switzerland)as retention system for the two implant overdenture. |
| Magnet Group | Active comparator | Procedure: Insertion of two screw type dental implants23 fully edentulous patients will receive Magnets (Institute Straumann AG, Basel Switzerland)as retention system for the two implant overdenture. |
| Locator Group | Active comparator | Procedure: Insertion of two screw type dental implants23 fully edentulous patients will receive Locator (Institute Straumann AG, Basel Switzerland)as retention system for the two implant overdenture. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fully mandibular edentulous patients
- 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 two screw type dental implantsAlso: Straumann (Institute Straumann AG, Basel, Switzerland)Each patient (of the 69 recruited) will receive 2 screw-type Straumann (Institute 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, in a 1-stage non-submerged procedure according to a strict protocol (Weingart D and ten Bruggenkate 2000). | Procedure or surgery | Locator Group, Magnet Group, Retentive Anchor Group |
Primary outcome
OHIP-EDENT linguistic and cultural adaptation in Romanian
Time frame: Two-weeks
Steps for validation: * linguistic and cultural adaptation of the original instrument to Romanian; * pilot study to assess face and content validity; * main study to assess the reliability and construct validity. OHIP-EDENT questionnaire includes 19-items addressing masticatory capacity, pleasure of eating, level of comfort, and relationship among others while wearing the prosthesis and detects the impact of oral health in the quality of life of edentulous adults wearing total prosthesis. Response categories:4=very often; 3=fairly often; 2=occasionally; 1=hardly ever; 0=never/don't know.
1 secondary outcome
Evaluation of patient satisfaction with the use of three different systems as retention for implant supported mandibular overdentures.
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 20032605Zani SR, Rivaldo EG, Frasca LC, Caye LF. Oral health impact profile and prosthetic condition in edentulous patients rehabilitated with implant-supported overdentures and fixed prostheses. J Oral Sci. 2009 Dec;51(4):535-43. doi: 10.2334/josnusd.51.535.
- Background: PubMed 11124735Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
- Background: PubMed 15592001Assad AS, Abd El-Dayem MA, Badawy MM. Comparison between mainly mucosa-supported and combined mucosa-implant-supported mandibular overdentures. Implant Dent. 2004 Dec;13(4):386-94. doi: 10.1097/01.id.0000144512.43654.08.
- Background: PubMed 11168258Weingart D, ten Bruggenkate CM. Treatment of fully edentulous patients with ITI implants. Clin Oral Implants Res. 2000;11 Suppl 1:69-82. doi: 10.1034/j.1600-0501.2000.011s1069.x.
- Background: PubMed 7495628Chan MF, Johnston C, Howell RA, Cawood JI. Prosthetic management of the atrophic mandible using endosseous implants and overdentures: a six year review. Br Dent J. 1995 Nov 11;179(9):329-37. doi: 10.1038/sj.bdj.4808917.
- Background: PubMed 10635189Davis DM, Packer ME. Mandibular overdentures stabilized by Astra Tech implants with either ball attachments or magnets: 5-year results. Int J Prosthodont. 1999 May-Jun;12(3):222-9.
- 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.
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 CLINIC
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 two screw type dental implants in people with Severe Atrophy of the Edentulous Mandible, 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 4 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?
OHIP-EDENT linguistic and cultural adaptation in Romanian (time frame: Two-weeks). 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 NCT01392456, which also lists 7 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.