Bone LossNCT05843825
Effect of Block-out Spacer to Pick up Locator Attachments to Retain Overdenture: Peri-implant and Alveolar Bone Changes
A study testing Surgical placement of dental implants and Overdenture supported by locator attachment system in people with Bone Loss, run by Mansoura University at 1 site in Egypt.
Trial summary
This study was conducted to radiographically evaluate peri-implant and alveolar bone height changes of locator attachments used for three implant assisted mandibular complete overdenture using two different pick up protocols. Read more about this study
- Who is it for?
- Ages 50 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- Surgical placement of dental implants and Overdenture supported by locator attachment system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2021to 21 Jan 2023
- 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 50 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good oral hygiene practiced by edentulous patients.
- Completely edentulous maxillary and mandibular arches (at least six months since last extraction) .
- Mandibular residual alveolar ridge mucosa was healthy, firmly attached, well keratinized, free from any ridge flabbiness and even compressible mucosa as detected by palpitation with the blunt end of the mirror .
- Mandibular residual alveolar ridge form was U-shaped with accepted bone width, height and density as assessed by cone beam computed tomography.
- Angle's class I maxillo-mandibular relationship.
- Sufficient restorative space vertically not less than (8.5mm) and horizontally not less than (9 mm) which were verified by tentative jaw relation record and mounting on the articulator .
Who cannot join
- Systemic diseases relating to the bone resorption(e.g. osteoporosis , uncontrolled diabetes, osteogenesis imperfecta…etc).
- Administrated drugs that interfere with bone quality (e.g. corticosteroids, thyroxin, levothyroxine... etc).
- Patients with absolute contraindication for surgical implantation (recent myocardial infarction, cerebrovascular accident, valvular prosthesis surgery, immunosuppression, bleeding issues….etc).
- General contraindication for surgical procedures such as patient with head and neck radiotherapy and hepatic patients.
- Patients with relative contraindication: history of para functional habits such as bruxism, clenching and bad habits such as smoking and alcoholism .
- Local contraindication for surgical implantation (close proximity to vital structure, pathological lesion, remaining root not indicated for removal , localized bone defects or poor bone quality (D4)).
- Allergic reactions to titanium or to local anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Using Block-out Spacer During Picking up of Locator Attachments Used for Retaining 3 Implant Mandibular Complete Overdenture: Peri-implant and Alveolar Bone Height Changes
This study was conducted to radiographically evaluate peri-implant and alveolar bone height changes of locator attachments used for three implant assisted mandibular complete overdenture using two different pick up protocols.
Read the detailed description
This clinical trial was done to evaluate the effect of using block-out spacer during picking up of locator attachments used for retaining 3 implant mandibular complete overdenture regarding peri-implant and alveolar bone height changes.
Eighteen egyptian completely edentulous male patients were chosen from the Outpatient Clinic of the Prosthodontics Department, Faculty of Dentistry, Mansoura University, Egypt.
Patients received three implants one anterior in midline area and two posterior at first molar area .
Patients free from any systemic diseases relating to the bone resorption, not taking any drugs that interfere with bone quality .Patients with absolute contraindication for surgical implantation, general contraindication , relative contraindication ,local contraindication for surgical implantation , allergic reactions to titanium or to local anesthesia were excluded.
The main question it aims to answer is whether to use block-out spacer during picking up of locator attachments used for retaining 3 implant mandibular complete overdenture or not.
- Participants were given antibiotic prophylaxis (clavulanic acid with amoxicillin 1 gm twice/day) one hour prior to surgery and continued for 6-7 days postoperative .Also, 50 mg of non-steroid anti-inflammatory tablets and analgesic (Declophenac tab) were given twice daily for one week after surgery. In addition to, Antiseptic mouth wash (0.2% chlorohexidine) was started ten minutes before surgery and continued one week after surgery twice daily.
- Patients were asked for radiographic evaluation immediately (T0) and 6 (T6) then 12 months (T12) after picking up of locator attachments.
Researcher compared between Block out spacer group (BOS-G) and Without block out spacer group (WBOS-G)which were randomly assigned into two equal groups to see if using block out spacer during picking up of locator attachments used for retaining 3 implant mandibular complete overdenture is more beneficial regarding peri-implant and alveolar bone height changes or not.
- Conditions
- Bone Loss
- Being tested
- Surgical placement of dental implants, Overdenture supported by locator attachment system
- Keywords
- Peri-implant, Alveolar bone
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical placement of dental implantsProcedure or surgery
Three dental implants were placed (one anterior in midline area and two posterior at first molar area).
Overdenture supported by locator attachment systemDevice
Implants were loaded after three months by using locator attachments.
Control group:Iocator attachments picked up using block out spacer.
Study group:Iocator attachments picked up without using block out spacer
| Study group | Role | What they receive |
|---|---|---|
| (BOS-G) Block out spacer group | Active comparator | (BOS-G)(Control group) : Patients who would be delivered mandibular overdenture retained by three locator attachments picked up using block out spacer . Receives: Procedure: Surgical placement of dental implants; Device: Overdenture supported by locator attachment system |
| (WBOS-G) Without block out spacer group | Active comparator | (WBOS-G) (Study group): Patients who would be delivered mandibular overdenture retained by three locator attachments picked up without using block out spacer . Receives: Procedure: Surgical placement of dental implants; Device: Overdenture supported by locator attachment system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant bone height changes (bone loss)
Evaluations of vertical and horizontal peri-implant bone loss in mm by digital periapical radiography.
Measured: one year.
Secondary outcomes (1)
Residual alveolar bone height changes (bone loss)
Evaluations of vertical residual alveolar bone loss in mm by panoramic radiography.
Measured: one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start20 Jan 2021
- Primary completion23 Jan 2022
- Study completion21 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Parallel groups
- Model description
- Patients were randomly assigned into two equal groups . (BOS-G) Block out spacer group : patients who would be delivered mandibular implant overdenture retained by three locator attachments using block out spacer during pick up .(WBOS-G) Without block out spacer group : patients who would be delivered mandibular implant overdenture retained by three locator attachments without using block out spacer during pick up
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahma elhussany mohammed, Mansoura University
- Investigators
- Rahma El Hussany, MD, Principal investigator, Mansoura University Faculty of Dentistry Prosthodontics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843825
- Sponsor's protocol ID
- M11071020
- Status last verified
- May 2023
- First submitted
- 21 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Block-out Spacer During Picking up of Locator Attachments Used for Retaining 3 Implant Mandibular Complete Overdenture: Peri-implant and Alveolar Bone Height Changes
- ClinicalTrials.gov ID
- NCT05843825
- Acronym / sponsor ID
- M11071020
- Conditions
- Bone Loss
- Keywords
- Peri-implant, Alveolar bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 23 Jan 2022 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 6 May 2023 (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 study was conducted to radiographically evaluate peri-implant and alveolar bone height changes of locator attachments used for three implant assisted mandibular complete overdenture using two different pick up protocols.
Detailed description
This clinical trial was done to evaluate the effect of using block-out spacer during picking up of locator attachments used for retaining 3 implant mandibular complete overdenture regarding peri-implant and alveolar bone height changes.
Eighteen egyptian completely edentulous male patients were chosen from the Outpatient Clinic of the Prosthodontics Department, Faculty of Dentistry, Mansoura University, Egypt.
Patients received three implants one anterior in midline area and two posterior at first molar area .
Patients free from any systemic diseases relating to the bone resorption, not taking any drugs that interfere with bone quality .Patients with absolute contraindication for surgical implantation, general contraindication , relative contraindication ,local contraindication for surgical implantation , allergic reactions to titanium or to local anesthesia were excluded.
The main question it aims to answer is whether to use block-out spacer during picking up of locator attachments used for retaining 3 implant mandibular complete overdenture or not.
- Participants were given antibiotic prophylaxis (clavulanic acid with amoxicillin 1 gm twice/day) one hour prior to surgery and continued for 6-7 days postoperative .Also, 50 mg of non-steroid anti-inflammatory tablets and analgesic (Declophenac tab) were given twice daily for one week after surgery. In addition to, Antiseptic mouth wash (0.2% chlorohexidine) was started ten minutes before surgery and continued one week after surgery twice daily.
- Patients were asked for radiographic evaluation immediately (T0) and 6 (T6) then 12 months (T12) after picking up of locator attachments.
Researcher compared between Block out spacer group (BOS-G) and Without block out spacer group (WBOS-G)which were randomly assigned into two equal groups to see if using block out spacer during picking up of locator attachments used for retaining 3 implant mandibular complete overdenture is more beneficial regarding peri-implant and alveolar bone height changes or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomly assigned into two equal groups . (BOS-G) Block out spacer group : patients who would be delivered mandibular implant overdenture retained by three locator attachments using block out spacer during pick up .(WBOS-G) Without block out spacer group : patients who would be delivered mandibular implant overdenture retained by three locator attachments without using block out spacer during pick up
| Arm | Type | Receives |
|---|---|---|
| (BOS-G) Block out spacer group | Active comparator | Procedure: Surgical placement of dental implants, Device: Overdenture supported by locator attachment system(BOS-G)(Control group) : Patients who would be delivered mandibular overdenture retained by three locator attachments picked up using block out spacer . |
| (WBOS-G) Without block out spacer group | Active comparator | Procedure: Surgical placement of dental implants, Device: Overdenture supported by locator attachment system(WBOS-G) (Study group): Patients who would be delivered mandibular overdenture retained by three locator attachments picked up without using block out spacer . |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Good oral hygiene practiced by edentulous patients.
- Completely edentulous maxillary and mandibular arches (at least six months since last extraction) .
- Mandibular residual alveolar ridge mucosa was healthy, firmly attached, well keratinized, free from any ridge flabbiness and even compressible mucosa as detected by palpitation with the blunt end of the mirror .
- Mandibular residual alveolar ridge form was U-shaped with accepted bone width, height and density as assessed by cone beam computed tomography.
- Angle's class I maxillo-mandibular relationship.
Key exclusion criteria (7 listed)
- Systemic diseases relating to the bone resorption(e.g. osteoporosis , uncontrolled diabetes, osteogenesis imperfecta…etc).
- Administrated drugs that interfere with bone quality (e.g. corticosteroids, thyroxin, levothyroxine... etc).
- Patients with absolute contraindication for surgical implantation (recent myocardial infarction, cerebrovascular accident, valvular prosthesis surgery, immunosuppression, bleeding issues….etc).
- General contraindication for surgical procedures such as patient with head and neck radiotherapy and hepatic patients.
- Patients with relative contraindication: history of para functional habits such as bruxism, clenching and bad habits such as smoking and alcoholism .
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 |
|---|---|---|
| Surgical placement of dental implantsThree dental implants were placed (one anterior in midline area and two posterior at first molar area). | Procedure or surgery | (BOS-G) Block out spacer group, (WBOS-G) Without block out spacer group |
| Overdenture supported by locator attachment systemImplants were loaded after three months by using locator attachments. Control group:Iocator attachments picked up using block out spacer. Study group:Iocator attachments picked up without using block out spacer | Device | (BOS-G) Block out spacer group, (WBOS-G) Without block out spacer group |
Primary outcome
Peri-implant bone height changes (bone loss)
Time frame: one year.
Evaluations of vertical and horizontal peri-implant bone loss in mm by digital periapical radiography.
1 secondary outcome
Residual alveolar bone height changes (bone loss)
Time frame: one 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 6 May 2023.
- 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.
Rahma El Hussany, MD principal investigator
Mansoura University Faculty of Dentistry Prosthodontics Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical placement of dental implants and Overdenture supported by locator attachment system in people with Bone Loss, 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 6 inclusion and 7 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 6 May 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 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?
Peri-implant bone height changes (bone loss) (time frame: one 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 6 May 2023.