Patient SatisfactionNCT06572891
Compressive Single-piece Implants for Immediate Rehabilitation of Edentulous Maxillectomy Patients
A study testing Maxillary obturator and Implant supported obturator in people with Patient Satisfaction, run by Mansoura University at 1 site in Egypt.
Trial summary
This within-patient study aimed to compare the satisfaction and oral health-related quality of life (OHRQoL) of edentulous maxillectomy patients with and without immediately loaded implant-supported obturator prostheses using single-piece compressive implants. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Maxillary obturator and Implant supported obturator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 7 May 2023to 20 Jul 2024
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a status eligible for implants after partial or total maxillectomy or partial or total loss of the maxilla.
- Residual alveolar ridge quantity and quality will be verified by cone beam computed tomography (CBCT) especially in the proposed implant sites.
Who cannot join
- Patients with systemic diseases that interfere with surgical implant procedures e.g., uncontrolled diabetes or osteoporosis.
- Radiation therapy or chemotherapy to the head and neck area (currently or time interval less than 6-months)
- Patients with local inflammation that may cause interference with implant placement.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry, mansoura university
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Compressive Single-piece Implants for Immediate Rehabilitation of Edentulous Maxillectomy Patients with Compromised Ridge: a Study of Patient Satisfaction and Oral Health Related Quality of Life
This within-patient study aimed to compare the satisfaction and oral health-related quality of life (OHRQoL) of edentulous maxillectomy patients with and without immediately loaded implant-supported obturator prostheses using single-piece compressive implants.
Read the detailed description
- Inclusion criteria:
- Patients with a status eligible for implants after partial or total maxillectomy or partial or total loss of the maxilla.
- Residual alveolar ridge quantity and quality as verified by cone beam computed tomography (CBCT), especially in the proposed implant sites.
- Exclusion Criteria:
- Patients with systemic diseases that interfere with surgical implant procedures e.g., uncontrolled diabetes or osteoporosis.
- Radiation therapy or chemotherapy to the head and neck area (currently or time interval less than 6 months)
- Patients with local inflammation that may cause interference with implant placement.
All patients were informed about the detailed treatment plan and received a written informed consent to be signed.
II) Preparation of the patient for implant placement:
- Fabrication of maxillary obturator.
- Cone beam computed tomography (CBCT) was performed for all patients to accurately plan implant location, diameter, and angulation.
III) Surgical phase:
- Surgery was performed under local anaesthesia.
- All patients received single-piece compressive implants in the proper positions according to the case demands.
- The patients were prescribed systemic antibiotics for one week, anti-inflammatory, analgesic, and mouthwash.
IV) Prosthetic phase:
- Necks of placed implants bent up to 15 degrees to be parallel placed.
- The maxillary obturator was adjusted on the poured mode, and modified and access holes made above the abutment were finally relined in the patient's mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol.
IV) Evaluation:
- Patient Satisfaction Based on Visual Analog Scale (VAS)
- Oral health impact profile for edentulous patient (OHIP-EDENT)
- Obturator Functioning Scale
- Conditions
- Patient Satisfaction
- Being tested
- Maxillary obturator, Implant supported obturator
- Keywords
- VAS, OHIP-EDENT, Obturator Functioning Scale
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary obturatorOther
conventional acrylic obturator
Implant supported obturatorOther
Implants inserted as planned The necks of the implants were bent up to 15 degrees to be parallel.
- The maxillary obturator was adjusted on the poured mode, modified and access holes will be made above the abutment to be finally relined in the patient mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol.
- Impressions were made
| Study group | Role | What they receive |
|---|---|---|
| Conventional maxillary obturator | Active comparator | conventional acrylic obturator for each patient Receives: Other: Maxillary obturator |
| Implant supported maxillary obturator | Active comparator | Implant-supported maxillary obturator (compressive implants) Receives: Other: Implant supported obturator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient Satisfaction Based on Visual Analog Scale The patients were asked to rate their overall satisfaction with the dentures on a 100-mm visual analogue scale (VAS) for each type of prosthesis. The anchor of the left end of the VAS was defined as 'completely dissatisfied' and that of the opposite side as 'completely satisfied'
Measured: 6 months
Secondary outcomes (2)
Oral health impact profile for edentulous patient (OHIP-EDENT)
Oral health impact profile for edentulous patients (OHIP-EDENT). The total 19 items are defined to measure seven domains: (1) functional limitation (3 items), (2) pain (4 items), (3) psychological discomfort (2 items), (4) physical disability (3 items), (5) psychological disability (2 items), (6) social disability (3 items), and (7) handicap(2 items). Each item is scored on a Likert scale from 1 ('Never') to 5 ('Very often'). The outcomes of the OHIP-EDENT can have ranged from 19 to 95. A score of 19 means that dental problems do not affect daily life at all, whereas a score of 95 means that dental problems affect daily life very often.
Measured: 6 months
- Obturator Functioning Scale
Obturator functioning scale was assessed in 1-15 questions in terms of no difficulty on a 5-point Likert Scale. Points 1 represent "not at all difficult" and point 2 stood for "a little difficult". Point 1 and 2 were considered as "No Difficulty" on the scale. Points 3, stood for 'somewhat difficult', point 4 for 'very much difficult' and point 5 for 'extremely difficult' and point 3, 4, and 5 were considered as 'Difficulty'.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start7 May 2023
- Primary completion20 Jun 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572891
- Sponsor's protocol ID
- M0104023RP
- Status last verified
- Apr 2023
- First submitted
- 23 Aug 2024
- Last updated
- 23 Sep 2024
- 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 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compressive Single-piece Implants for Immediate Rehabilitation of Edentulous Maxillectomy Patients with Compromised Ridge: a Study of Patient Satisfaction and Oral Health Related Quality of Life
- ClinicalTrials.gov ID
- NCT06572891
- Acronym / sponsor ID
- M0104023RP
- Conditions
- Patient Satisfaction
- Keywords
- VAS, OHIP-EDENT, Obturator Functioning Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 7 May 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 27 Aug 2024 (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.
This within-patient study aimed to compare the satisfaction and oral health-related quality of life (OHRQoL) of edentulous maxillectomy patients with and without immediately loaded implant-supported obturator prostheses using single-piece compressive implants.
Detailed description
- Inclusion criteria:
- Patients with a status eligible for implants after partial or total maxillectomy or partial or total loss of the maxilla.
- Residual alveolar ridge quantity and quality as verified by cone beam computed tomography (CBCT), especially in the proposed implant sites.
- Exclusion Criteria:
- Patients with systemic diseases that interfere with surgical implant procedures e.g., uncontrolled diabetes or osteoporosis.
- Radiation therapy or chemotherapy to the head and neck area (currently or time interval less than 6 months)
- Patients with local inflammation that may cause interference with implant placement.
All patients were informed about the detailed treatment plan and received a written informed consent to be signed.
II) Preparation of the patient for implant placement:
- Fabrication of maxillary obturator.
- Cone beam computed tomography (CBCT) was performed for all patients to accurately plan implant location, diameter, and angulation.
III) Surgical phase:
- Surgery was performed under local anaesthesia.
- All patients received single-piece compressive implants in the proper positions according to the case demands.
- The patients were prescribed systemic antibiotics for one week, anti-inflammatory, analgesic, and mouthwash.
IV) Prosthetic phase:
- Necks of placed implants bent up to 15 degrees to be parallel placed.
- The maxillary obturator was adjusted on the poured mode, and modified and access holes made above the abutment were finally relined in the patient's mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol.
IV) Evaluation:
- Patient Satisfaction Based on Visual Analog Scale (VAS)
- Oral health impact profile for edentulous patient (OHIP-EDENT)
- Obturator Functioning Scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional maxillary obturator | Active comparator | Other: Maxillary obturatorconventional acrylic obturator for each patient |
| Implant supported maxillary obturator | Active comparator | Other: Implant supported obturatorImplant-supported maxillary obturator (compressive implants) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a status eligible for implants after partial or total maxillectomy or partial or total loss of the maxilla.
- Residual alveolar ridge quantity and quality will be verified by cone beam computed tomography (CBCT) especially in the proposed implant sites.
Key exclusion criteria (3 listed)
- Patients with systemic diseases that interfere with surgical implant procedures e.g., uncontrolled diabetes or osteoporosis.
- Radiation therapy or chemotherapy to the head and neck area (currently or time interval less than 6-months)
- Patients with local inflammation that may cause interference with implant placement.
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 obturatorconventional acrylic obturator | Other | Conventional maxillary obturator |
| Implant supported obturatorImplants inserted as planned The necks of the implants were bent up to 15 degrees to be parallel. * The maxillary obturator was adjusted on the poured mode, modified and access holes will be made above the abutment to be finally relined in the patient mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol. * Impressions were made | Other | Implant supported maxillary obturator |
Primary outcome
Patient Satisfaction
Time frame: 6 months
Patient Satisfaction Based on Visual Analog Scale The patients were asked to rate their overall satisfaction with the dentures on a 100-mm visual analogue scale (VAS) for each type of prosthesis. The anchor of the left end of the VAS was defined as 'completely dissatisfied' and that of the opposite side as 'completely satisfied'
2 secondary outcomes
Oral health impact profile for edentulous patient (OHIP-EDENT)
Time frame: 6 months
- Obturator Functioning Scale
Time frame: 6 months
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 23 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 obturator and Implant supported obturator in people with Patient Satisfaction, run by Mansoura University 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 2 inclusion and 3 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 23 Sep 2024. 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: 6 months). 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 23 Sep 2024.