Completely Edentulous PatientsNCT04694209
Patient Satisfaction and OHRQoL In Removable Versus Fixed Implant Prostheses
A study testing maxillary and mandibular telescopic retained overdentures supported by 4 implants and maxillary and mandibular screw retained hybrid prostheses supported by 4 implants in people with Completely Edentulous Patients, run by Iman Abd-ElWahab Radi, PhD at 1 site in Egypt.
Trial summary
Objectives to evaluate the oral health-related quality of life and patient satisfaction in completely edentulous patients, when restored by maxillary and mandibular fixed (screw-retained) or removable telescopic retained implant supported prosthesis. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Completely Edentulous Patients
- What is being tested?
- maxillary and mandibular telescopic retained overdentures supported by 4 implants and maxillary and mandibular screw retained hybrid prostheses supported by 4 implants
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 28 Aug 2019
- 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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completely edentulous male patients with an age range from 40- 70 years.
- Patients with a HbA1c equal to or less than 7
- All patients should have normal maxillo-mandibular relationship (Angle class I).
- Patients should have maxillary and mandibular ridges at least 7mm in width and 13 mm in height in the interforaminal areas and in the esthetic zones (premolar to premolar regions), respectively. This accommodated a pre-planned implant size of 3.7mm x 10 or 11mm.
- The maxillary and mandibular ridges should be covered by keratinized attached mucosa at least 5mm in width.
- An interarch space between the edentulous maxillary and mandibular ridges should not be less than 22 mm to accommodate the planned maxillary and mandibular implant-supported prostheses. This was confirmed by mounted diagnostic casts.
- Patients who were cooperative and who were psychologically and mentally stable as revealed from the initial interview with the patients were considered eligible.
Who cannot join
- Females were excluded on purpose to prevent failures associated with osteoporosis and to avoid gender variability which definitely affects the results of patient satisfaction and OHIP.
- 2. Patients requiring hard or, soft tissue grafting of the proposed implant sites.
- 3. Heavy smokers (more than 10 cigarettes / day) or patients with para-functional habits like clenching or bruxism were excluded. This was important to decrease the risk of implant failure.
- 4. Patients with temporo-mandibular joint disorders were considered ineligible because of the expected occlusal disturbances.
- 5. Patients with systemic disease that might contra-indicate implants placement or affect osseointegration e.g. uncontrolled diabetes.
- 6. Patients who took chemo-or radiotherapy or any drug that might counter-affect the healing process or the quality of bone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment Of Patient Satisfaction and Oral-health Related Quality of Life In Completely Edentulous Patients Receiving Removable Implant Overdentures Versus Fixed Implant Overdentures: A Randomized Clinical Trial
Objectives to evaluate the oral health-related quality of life and patient satisfaction in completely edentulous patients, when restored by maxillary and mandibular fixed (screw-retained) or removable telescopic retained implant supported prosthesis. 19 patients were randomized to receive either a fixed or a removable maxillary and mandibular full arch implant prosthesis. They were then asked to answer the OHIP-14 and a patient satisfaction questionnaire at 2 weeks, 3, 6 and 12 months post-prosthetic insertion.
Read the detailed description
Interventions
General operative procedures:
Once the eligibility criteria were fulfilled in a patient, new complete maxillary and mandibular dentures were fabricated for this patient to allow for prosthetically driven implant placement. 4 implants were placed interforaminally so that they were parallel to each other. If the patient had an existing satisfactory denture, that was delivered at least six months ago, it was evaluated for retention, fit, support, stability, occlusion and esthetics. New and old dentures were later used for constructing the scan appliances.
The patients were randomly assigned into two groups with an allocation ratio 1:1. Simple randomization was done by preparing sequentially-numbered, opaque, sealed envelopes, that contained two-times folded cards with the treatment group written inside. Accordingly, the patients were assigned either to group T (control treatment/ telescopic retained implant supported removable overdentures) or group S (test treatment/ screw retained implant supported fixed prosthesis).
The intervention arm : Engaging (Internal hex) cylindrical, plastic patterns (Octa plastic cylinder, multi unit abutment, Red, Dentis, Daegu -Korea) were used to construct the primary copings of the telescopic prosthesis.The finished primary copings were scanned using a lab scanner (Shera Echo-scan 7. Dental Wings, Montreal-Canada). This was necessary to design and to mill the wax pattern of the secondary copings using CAD/CAM technology (Dental Wings Software, Dental Wings, Montreal -Canada). Secondary coping was designed to properly fit to the primary coping. The framework was then tried in. At that time it was ready for its intra-oral luting to the secondary copings.
the control treatment: Once adequate fit of the framework of the hybrid prosthesis was achieved, the wax of the trial denture was converted into heat-cured acrylic resin using conventional packing and flasking techniques. The prosthesis was finished, polished and screwed in the patient's mouth.
Lack of blinding of the operator, the participants and the assessor (patient) due to the obvious dissimilarity between the treatment arms, could have created performance and assessment bias. In an attempt to decrease the performance bias, randomization was delayed until the abutments were connected. When the prosthesis was delivered to the patient, they were requested to answer OHIP-14 and patient satisfaction questionnaires 2 weeks after prosthetic insertion, then 3, 6 and 12 months later.
The aim of this RCT was to evaluate patient satisfaction and oral-health related quality of life in completely edentulous patients receiving removable implant overdentures versus fixed implant hybrid restorations.
Data were statistically described in terms of mean +/- standard deviation (+/- SD), median and range. Comparison of ordinal variables between the study groups was done using Mann Whitney U test for independent samples. Within group comparison of the ordinal data was done using Friedmann test to detect significant differences between time in periods. This was followed by Wilcoxon signed rank test for paired comparisons. Two sided p values less than 0.05 was considered statistically significant. Additionally, a correlation between relevant domains of the OHIP-14 and the patient satisfaction questionnaires was done using Spearman rank correlation test. All statistical calculations were done using computer program IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 22 for Microsoft Windows
- Conditions
- Completely Edentulous Patients
- Being tested
- maxillary and mandibular telescopic retained overdentures supported by 4 implants, maxillary and mandibular screw retained hybrid prostheses supported by 4 implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary and mandibular telescopic retained overdentures supported by 4 implantsProcedure or surgery
The wax of the trial denture was converted into heat-cured acrylic resin using conventional packing and flasking techniques. The prosthesis was finished, polished and screwed in the patient's mouth. Engaging (Internal hex) cylindrical, plastic patterns (Octa plastic cylinder, multi unit abutment, Red, Dentis, Daegu -Korea) were used to construct the primary copings of the telescopic prosthesis.The finished primary copings were scanned using a lab scanner (Shera Echo-scan 7. Dental Wings, Montreal-Canada). This was necessary to design and to mill the wax pattern of the secondary copings using CAD/CAM technology (Dental Wings Software, Dental Wings, Montreal -Canada). Secondary coping was designed to properly fit to the primary coping. The framework was then tried in. At that time it was ready for its intra-oral luting to the secondary copings.
maxillary and mandibular screw retained hybrid prostheses supported by 4 implantsProcedure or surgery
Framework of the hybrid prosthesis is waxed using plastic copings attached to multiunit abutments. once the framework is finished , bite is recorded, teeth are set up and the waxed up prosthesis are tried in. IF accepted the wax is eliminated the wax up denture is converted inti heat cured acrylic resin
| Study group | Role | What they receive |
|---|---|---|
| Fixed implant supported prosthesis | Experimental | the prosthesis is an all-on-four prosthesis composed of a hybrid prosthesis. a metal framework, acrylic resin denture base and acrylic resin teeth Receives: Procedure: maxillary and mandibular screw retained hybrid prostheses supported by 4 implants |
| Removable implant supported prosthesis | Active comparator | the prosthesis is an all-on-four prosthesis composed of a telescopic retained overdenture, both primary and secondary copings are custom made. the secondary copings are conncetd via a metal framework Receives: Procedure: maxillary and mandibular telescopic retained overdentures supported by 4 implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
questionnaire. The patient satisfaction questionnaire is composed of 14 questions concerned with esthetics, speech, mastication, operative and prosthetic procedures, incidence of complications, pre-operative instructions, total time interval, cost, operator, hygienic procedures, overall experience as well as the willingness to repeat or refer others for the procedure.
Measured: 2 weeks after prosthetic insertion- 1 year
Secondary outcomes (1)
oral health related quality of life
OHIP-14 scoring
Measured: 2 weeks after prosthetic insertion- 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Nov 2017
- Primary completion30 Sep 2018
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Completely Edentulous PatientsStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iman Abd-ElWahab Radi, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Iman Abd-ElWahab Radi, PhD, Cairo University
- Investigators
- Amira kheidr, masters, Principal investigator, Cairo UniversityAmr El Khadem, phd, Study director, Cairo UniversitySamira Ibrahim, phd, Study chair, Cairo UniversityIman Radi, phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694209
- Sponsor's protocol ID
- 151017
- Status last verified
- Mar 2021
- First submitted
- 24 Dec 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Patient Satisfaction and Oral-health Related Quality of Life In Completely Edentulous Patients Receiving Removable Implant Overdentures Versus Fixed Implant Overdentures: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04694209
- Acronym / sponsor ID
- 151017
- Conditions
- Completely Edentulous Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Iman Abd-ElWahab Radi, PhDUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 5 Jan 2021 (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.
Objectives to evaluate the oral health-related quality of life and patient satisfaction in completely edentulous patients, when restored by maxillary and mandibular fixed (screw-retained) or removable telescopic retained implant supported prosthesis. 19 patients were randomized to receive either a fixed or a removable maxillary and mandibular full arch implant prosthesis. They were then asked to answer the OHIP-14 and a patient satisfaction questionnaire at 2 weeks, 3, 6 and 12 months post-prosthetic insertion.
Detailed description
Interventions
General operative procedures:
Once the eligibility criteria were fulfilled in a patient, new complete maxillary and mandibular dentures were fabricated for this patient to allow for prosthetically driven implant placement. 4 implants were placed interforaminally so that they were parallel to each other. If the patient had an existing satisfactory denture, that was delivered at least six months ago, it was evaluated for retention, fit, support, stability, occlusion and esthetics. New and old dentures were later used for constructing the scan appliances.
The patients were randomly assigned into two groups with an allocation ratio 1:1. Simple randomization was done by preparing sequentially-numbered, opaque, sealed envelopes, that contained two-times folded cards with the treatment group written inside. Accordingly, the patients were assigned either to group T (control treatment/ telescopic retained implant supported removable overdentures) or group S (test treatment/ screw retained implant supported fixed prosthesis).
The intervention arm : Engaging (Internal hex) cylindrical, plastic patterns (Octa plastic cylinder, multi unit abutment, Red, Dentis, Daegu -Korea) were used to construct the primary copings of the telescopic prosthesis.The finished primary copings were scanned using a lab scanner (Shera Echo-scan 7. Dental Wings, Montreal-Canada). This was necessary to design and to mill the wax pattern of the secondary copings using CAD/CAM technology (Dental Wings Software, Dental Wings, Montreal -Canada). Secondary coping was designed to properly fit to the primary coping. The framework was then tried in. At that time it was ready for its intra-oral luting to the secondary copings.
the control treatment: Once adequate fit of the framework of the hybrid prosthesis was achieved, the wax of the trial denture was converted into heat-cured acrylic resin using conventional packing and flasking techniques. The prosthesis was finished, polished and screwed in the patient's mouth.
Lack of blinding of the operator, the participants and the assessor (patient) due to the obvious dissimilarity between the treatment arms, could have created performance and assessment bias. In an attempt to decrease the performance bias, randomization was delayed until the abutments were connected. When the prosthesis was delivered to the patient, they were requested to answer OHIP-14 and patient satisfaction questionnaires 2 weeks after prosthetic insertion, then 3, 6 and 12 months later.
The aim of this RCT was to evaluate patient satisfaction and oral-health related quality of life in completely edentulous patients receiving removable implant overdentures versus fixed implant hybrid restorations.
Data were statistically described in terms of mean +/- standard deviation (+/- SD), median and range. Comparison of ordinal variables between the study groups was done using Mann Whitney U test for independent samples. Within group comparison of the ordinal data was done using Friedmann test to detect significant differences between time in periods. This was followed by Wilcoxon signed rank test for paired comparisons. Two sided p values less than 0.05 was considered statistically significant. Additionally, a correlation between relevant domains of the OHIP-14 and the patient satisfaction questionnaires was done using Spearman rank correlation test. All statistical calculations were done using computer program IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 22 for Microsoft Windows
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed implant supported prosthesis | Experimental | Procedure: maxillary and mandibular screw retained hybrid prostheses supported by 4 implantsthe prosthesis is an all-on-four prosthesis composed of a hybrid prosthesis. a metal framework, acrylic resin denture base and acrylic resin teeth |
| Removable implant supported prosthesis | Active comparator | Procedure: maxillary and mandibular telescopic retained overdentures supported by 4 implantsthe prosthesis is an all-on-four prosthesis composed of a telescopic retained overdenture, both primary and secondary copings are custom made. the secondary copings are conncetd via a metal framework |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Completely edentulous male patients with an age range from 40- 70 years.
- Patients with a HbA1c equal to or less than 7
- All patients should have normal maxillo-mandibular relationship (Angle class I).
- Patients should have maxillary and mandibular ridges at least 7mm in width and 13 mm in height in the interforaminal areas and in the esthetic zones (premolar to premolar regions), respectively. This accommodated a pre-planned implant size of 3.7mm x 10 or 11mm.
- The maxillary and mandibular ridges should be covered by keratinized attached mucosa at least 5mm in width.
Key exclusion criteria (6 listed)
- Females were excluded on purpose to prevent failures associated with osteoporosis and to avoid gender variability which definitely affects the results of patient satisfaction and OHIP.
- 2. Patients requiring hard or, soft tissue grafting of the proposed implant sites.
- 3. Heavy smokers (more than 10 cigarettes / day) or patients with para-functional habits like clenching or bruxism were excluded. This was important to decrease the risk of implant failure.
- 4. Patients with temporo-mandibular joint disorders were considered ineligible because of the expected occlusal disturbances.
- 5. Patients with systemic disease that might contra-indicate implants placement or affect osseointegration e.g. uncontrolled diabetes.
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 |
|---|---|---|
| maxillary and mandibular telescopic retained overdentures supported by 4 implantsThe wax of the trial denture was converted into heat-cured acrylic resin using conventional packing and flasking techniques. The prosthesis was finished, polished and screwed in the patient's mouth. Engaging (Internal hex) cylindrical, plastic patterns (Octa plastic cylinder, multi unit abutment, Red, Dentis, Daegu -Korea) were used to construct the primary copings of the telescopic prosthesis.The finished primary copings were scanned using a lab scanner (Shera Echo-scan 7. Dental Wings, Montreal-Canada). This was necessary to design and to mill the wax pattern of the secondary copings using CAD/CAM technology (Dental Wings Software, Dental Wings, Montreal -Canada). Secondary coping was designed to properly fit to the primary coping. The framework was then tried in. At that time it was ready for its intra-oral luting to the secondary copings. | Procedure or surgery | Removable implant supported prosthesis |
| maxillary and mandibular screw retained hybrid prostheses supported by 4 implantsFramework of the hybrid prosthesis is waxed using plastic copings attached to multiunit abutments. once the framework is finished , bite is recorded, teeth are set up and the waxed up prosthesis are tried in. IF accepted the wax is eliminated the wax up denture is converted inti heat cured acrylic resin | Procedure or surgery | Fixed implant supported prosthesis |
Primary outcome
patient satisfaction
Time frame: 2 weeks after prosthetic insertion- 1 year
questionnaire. The patient satisfaction questionnaire is composed of 14 questions concerned with esthetics, speech, mastication, operative and prosthetic procedures, incidence of complications, pre-operative instructions, total time interval, cost, operator, hygienic procedures, overall experience as well as the willingness to repeat or refer others for the procedure.
1 secondary outcome
oral health related quality of life
Time frame: 2 weeks after prosthetic insertion- 1 year
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 10 Mar 2021.
- 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.
Amira kheidr, masters principal investigator
Cairo University
Amr El Khadem, phd study director
Cairo University
Samira Ibrahim, phd study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maxillary and mandibular telescopic retained overdentures supported by 4 implants and maxillary and mandibular screw retained hybrid prostheses supported by 4 implants in people with Completely Edentulous Patients, run by Iman Abd-ElWahab Radi, PhD at 1 site in Egypt.
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 6 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 10 Mar 2021. 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 Egypt. 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?
patient satisfaction (time frame: 2 weeks after prosthetic insertion- 1 year). It is what the study was designed to measure, not a finding.
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 10 Mar 2021.