Problem With DenturesNCT03866031
Comparative Study of Mandibular Dentures Immediately Loaded on Implants or Mini-implants
A study testing implant-supported mandibular overdenture in people with Problem With Dentures, run by Damascus University at 1 site in Syria.
Trial summary
3 groups of immediately Loaded implant-supported overdenture patients will be evaluated (overdentures supported by two standard-sized implant, overdentures supported by 4 mini implant d: 3.2 mm ,overdentures supported by 4 mini implant d: 2.75 mm) regarding stability, masticatory efficiency, patient's satisfaction… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Problem With Dentures
- What is being tested?
- implant-supported mandibular overdenture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSyria
- Study dates
- 3 Apr 2019to 12 Dec 2022
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patient should be completely edentulous for at least 6 months.
- first class jaw relation.
- adequate bone for an implant length of at least 10 mm and diameter of at least 2.75 mm.
- the patients should be able to speak and write in arabic.
Who cannot join
- 1) patients who received radiotherapy to the head or neck region for tumors. (2) a history of chemotherapy. (3) patients on long-term steroids, or bisphosphonates. (4) heavy smokers. (5) patients with physical and mental dis -abilities that interfere with the maintenance of implants.
- uncontrolled systematic disease that could compromise implant surgery. (7) extreme bruxism. (8) infectious disease. (9) temporomandibular joint dysfunction.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Removable prosthodontics department and implantation department / Faculty of dental medicine / Damascus univ
Damascus
About this study
Official title: Comparative Clinical and Radiographic Study of Mandibular Overdentures Immediately Loaded on Implants or Mini-implants Randomized Control Trial
3 groups of immediately Loaded implant-supported overdenture patients will be evaluated (overdentures supported by two standard-sized implant, overdentures supported by 4 mini implant d: 3.2 mm ,overdentures supported by 4 mini implant d: 2.75 mm) regarding stability, masticatory efficiency, patient's satisfaction, oral health related quality of life, Peri-implant crestal alveolar bone loss.
Read the detailed description
The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.
The evaluations of the primary outcomes will be conducted before implantation and after (1 - 3 - 6 - 12 - 18), except Peri-implant crestal alveolar bone loss will be conducted only after (0 - 3 - 6 - 12 - 18).
- Conditions
- Problem With Dentures
- Being tested
- implant-supported mandibular overdenture
- Keywords
- Implant, overdenture, Immediate loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant-supported mandibular overdentureOther
The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.
| Study group | Role | What they receive |
|---|---|---|
| M:2.75 | Experimental | 12 Patients will be provided with 4 mini implant-supported mandibular overdentures d: 2.75 mm Receives: Other: implant-supported mandibular overdenture |
| M3.25 | Experimental | 12 Patients will be provided with 4 mini implant-supported mandibular overdentures d: 3.25 mm Receives: Other: implant-supported mandibular overdenture |
| S3.75 | Experimental | 12 Patients will be provided with 2 standard sized implant-supported mandibular overdentures d: 3.75 mm Receives: Other: implant-supported mandibular overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in denture stability
The evaluation will be by Digital force gauge, a Hook of orthodontic wire (18 gauge diameter) will attach to the labial flange of overdenture, the other end of wire will connect to the force gauge which will be pull vertically upward until denture retention lost, and then reading will record 3 times and means value will calculate.
Measured: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
change in masticatory efficiency
The evaluation will be by test food filtering device,Where the subjects will chew a measured portion of test food (peanuts) for 20 strokes. The test food will strain through mesh sieve (2 mm opening). The volume of food remaining on the sieve and that passing through the sieve determined the masticatory performance.
Measured: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
change in patient's satisfaction
The evaluation will be by 100 mm Visual Analog Scale (VAS), for which higher scores indicate greater satisfaction, They will be asked to rate their level of comfort, ability to chew, stability, ability to speak, ease of cleaning their prostheses and their general satisfaction.
Measured: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
change in oral health related quality of life
The evaluation will be by oral health impact profile of edentulous (Ohip-Edent) instrument, Patients will answer questions of ohip-edent which included 7 domains: functional limitation, physical pain, psychological discomfort, physical disability, Psychological disability, Social disability, Handicap. Responses will made on a five-grade Likert-type scale:
0=never ; 1=hardly ever ; 2=occasionally ; 3= fairly often ; 4= very often. disability, social disability and handicap
Measured: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
change in Peri-implant crestal alveolar bone loss
The evaluation will be by panoramic radiogram, Peri-implant vertical and horizontal alveolar bone loss will measure (in mm) at the mesial and distal surface of each implant.
implant
Measured: T1: on same day of loaded; T2: 3 month after loaded; T3: 6 month after loaded; T4:12 month after loaded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start3 Apr 2019
- Primary completion20 Jun 2021
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Problem With DenturesStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heba M Moftah, DDS MSc, Principal investigator, PhD student at Removable Prosthodontics Department, faculty of dental medicine, Damascus UnivMohannad H Al-saadi, DDS MSc PhD, Study director, Professor of Removable Prosthodontics, faculty of dental medicine, Damascus UnivKhaldoun A Darwich, DDS Msc PhD, Study director, Professor of Oral and Maxillofacial surgery, faculty of dental medicine, Damascus Univ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866031
- Sponsor's protocol ID
- UDDS-RemPro-01-2019
- Status last verified
- Feb 2023
- First submitted
- 2 Mar 2019
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zygogiannis K, Aartman IH, Parsa A, Tahmaseb A, Wismeijer D. Implant Mandibular Overdentures Retained by Immediately Loaded Implants: A 1-Year Randomized Trial Comparing the Clinical and Radiographic Outcomes Between Mini Dental Implants and Standard-Sized Implants. Int J Oral Maxillofac Implants. 2017 Nov/Dec;32(6):1377-1388. doi: 10.11607/jomi.5981.
PubMed 29140382Kanazawa M, Tanoue M, Miyayasu A, Takeshita S, Sato D, Asami M, Lam TV, Thu KM, Oda K, Komagamine Y, Minakuchi S, Feine J. The patient general satisfaction of mandibular single-implant overdentures and conventional complete dentures: Study protocol for a randomized crossover trial. Medicine (Baltimore). 2018 May;97(20):e10721. doi: 10.1097/MD.0000000000010721.
PubMed 29768340ALHarthi SS, BinShabaib MS, Ahmed HB, Mehmood A, Khan J, Javed F. Comparison of peri-implant clinical and radiographic inflammatory parameters among cigarette and waterpipe (narghile) smokers and never-smokers. J Periodontol. 2018 Feb;89(2):213-218. doi: 10.1902/jop.2017.170358.
PubMed 28777038Kappel S, Giannakopoulos NN, Eberhard L, Rammelsberg P, Eiffler C. Immediate Loading of Dental Implants in Edentulous Mandibles by Use of Locator(R) Attachments or Dolder(R) Bars: Two-Year Results from a Prospective Randomized Clinical Study. Clin Implant Dent Relat Res. 2016 Aug;18(4):752-61. doi: 10.1111/cid.12349. Epub 2015 May 7.
PubMed 25950679Kroll P, Hou L, Radaideh H, Sharifi N, Han PP, Mulligan R, Enciso R. Oral Health-Related Outcomes in Edentulous Patients Treated With Mandibular Implant-Retained Dentures Versus Complete Dentures: Systematic Review With Meta-Analyses. J Oral Implantol. 2018 Aug;44(4):313-324. doi: 10.1563/aaid-joi-D-17-00210. Epub 2018 Feb 19.
PubMed 29457932
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical and Radiographic Study of Mandibular Overdentures Immediately Loaded on Implants or Mini-implants Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03866031
- Acronym / sponsor ID
- UDDS-RemPro-01-2019
- Conditions
- Problem With Dentures
- Keywords
- Implant, overdenture, Immediate loading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 7 Mar 2019 (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.
3 groups of immediately Loaded implant-supported overdenture patients will be evaluated (overdentures supported by two standard-sized implant, overdentures supported by 4 mini implant d: 3.2 mm ,overdentures supported by 4 mini implant d: 2.75 mm) regarding stability, masticatory efficiency, patient's satisfaction, oral health related quality of life, Peri-implant crestal alveolar bone loss.
Detailed description
The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.
The evaluations of the primary outcomes will be conducted before implantation and after (1 - 3 - 6 - 12 - 18), except Peri-implant crestal alveolar bone loss will be conducted only after (0 - 3 - 6 - 12 - 18).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| M:2.75 | Experimental | Other: implant-supported mandibular overdenture12 Patients will be provided with 4 mini implant-supported mandibular overdentures d: 2.75 mm |
| M3.25 | Experimental | Other: implant-supported mandibular overdenture12 Patients will be provided with 4 mini implant-supported mandibular overdentures d: 3.25 mm |
| S3.75 | Experimental | Other: implant-supported mandibular overdenture12 Patients will be provided with 2 standard sized implant-supported mandibular overdentures d: 3.75 mm |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the patient should be completely edentulous for at least 6 months.
- first class jaw relation.
- adequate bone for an implant length of at least 10 mm and diameter of at least 2.75 mm.
- the patients should be able to speak and write in arabic.
Key exclusion criteria (2 listed)
- 1) patients who received radiotherapy to the head or neck region for tumors. (2) a history of chemotherapy. (3) patients on long-term steroids, or bisphosphonates. (4) heavy smokers. (5) patients with physical and mental dis -abilities that interfere with the maintenance of implants.
- uncontrolled systematic disease that could compromise implant surgery. (7) extreme bruxism. (8) infectious disease. (9) temporomandibular joint dysfunction.
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 |
|---|---|---|
| implant-supported mandibular overdentureThe implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures. | Other | M3.25, M:2.75, S3.75 |
Primary outcome
change in denture stability
Time frame: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
The evaluation will be by Digital force gauge, a Hook of orthodontic wire (18 gauge diameter) will attach to the labial flange of overdenture, the other end of wire will connect to the force gauge which will be pull vertically upward until denture retention lost, and then reading will record 3 times and means value will calculate.
change in masticatory efficiency
Time frame: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
The evaluation will be by test food filtering device,Where the subjects will chew a measured portion of test food (peanuts) for 20 strokes. The test food will strain through mesh sieve (2 mm opening). The volume of food remaining on the sieve and that passing through the sieve determined the masticatory performance.
change in patient's satisfaction
Time frame: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
The evaluation will be by 100 mm Visual Analog Scale (VAS), for which higher scores indicate greater satisfaction, They will be asked to rate their level of comfort, ability to chew, stability, ability to speak, ease of cleaning their prostheses and their general satisfaction.
change in oral health related quality of life
Time frame: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
The evaluation will be by oral health impact profile of edentulous (Ohip-Edent) instrument, Patients will answer questions of ohip-edent which included 7 domains: functional limitation, physical pain, psychological discomfort, physical disability, Psychological disability, Social disability, Handicap. Responses will made on a five-grade Likert-type scale: 0=never ; 1=hardly ever ; 2=occasionally ; 3= fairly often ; 4= very often. disability, social disability and handicap
change in Peri-implant crestal alveolar bone loss
Time frame: T1: on same day of loaded; T2: 3 month after loaded; T3: 6 month after loaded; T4:12 month after loaded
The evaluation will be by panoramic radiogram, Peri-implant vertical and horizontal alveolar bone loss will measure (in mm) at the mesial and distal surface of each implant. implant
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 9 Feb 2023.
- Background: PubMed 29140382Zygogiannis K, Aartman IH, Parsa A, Tahmaseb A, Wismeijer D. Implant Mandibular Overdentures Retained by Immediately Loaded Implants: A 1-Year Randomized Trial Comparing the Clinical and Radiographic Outcomes Between Mini Dental Implants and Standard-Sized Implants. Int J Oral Maxillofac Implants. 2017 Nov/Dec;32(6):1377-1388. doi: 10.11607/jomi.5981.
- Background: PubMed 29768340Kanazawa M, Tanoue M, Miyayasu A, Takeshita S, Sato D, Asami M, Lam TV, Thu KM, Oda K, Komagamine Y, Minakuchi S, Feine J. The patient general satisfaction of mandibular single-implant overdentures and conventional complete dentures: Study protocol for a randomized crossover trial. Medicine (Baltimore). 2018 May;97(20):e10721. doi: 10.1097/MD.0000000000010721.
- Background: PubMed 28777038ALHarthi SS, BinShabaib MS, Ahmed HB, Mehmood A, Khan J, Javed F. Comparison of peri-implant clinical and radiographic inflammatory parameters among cigarette and waterpipe (narghile) smokers and never-smokers. J Periodontol. 2018 Feb;89(2):213-218. doi: 10.1902/jop.2017.170358.
- Background: PubMed 25950679Kappel S, Giannakopoulos NN, Eberhard L, Rammelsberg P, Eiffler C. Immediate Loading of Dental Implants in Edentulous Mandibles by Use of Locator(R) Attachments or Dolder(R) Bars: Two-Year Results from a Prospective Randomized Clinical Study. Clin Implant Dent Relat Res. 2016 Aug;18(4):752-61. doi: 10.1111/cid.12349. Epub 2015 May 7.
- Background: PubMed 29457932Kroll P, Hou L, Radaideh H, Sharifi N, Han PP, Mulligan R, Enciso R. Oral Health-Related Outcomes in Edentulous Patients Treated With Mandibular Implant-Retained Dentures Versus Complete Dentures: Systematic Review With Meta-Analyses. J Oral Implantol. 2018 Aug;44(4):313-324. doi: 10.1563/aaid-joi-D-17-00210. Epub 2018 Feb 19.
- Individual participant dataSharing planned: No
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.
Heba M Moftah, DDS MSc principal investigator
PhD student at Removable Prosthodontics Department, faculty of dental medicine, Damascus Univ
Mohannad H Al-saadi, DDS MSc PhD study director
Professor of Removable Prosthodontics, faculty of dental medicine, Damascus Univ
Khaldoun A Darwich, DDS Msc PhD study director
Professor of Oral and Maxillofacial surgery, faculty of dental medicine, Damascus Univ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant-supported mandibular overdenture in people with Problem With Dentures, run by Damascus University at 1 site in Syria.
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 2 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 9 Feb 2023. 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 Syria. 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?
change in denture stability (time frame: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded). The study lists 5 primary outcomes in all. 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 NCT03866031, which also lists 5 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 9 Feb 2023.