Vertical Alveolar Bone LossNCT05290376
Clinical Evaluation of RTX Locator Attachments for Implant-supported Mandibular Complete Overdenture
A study testing surgical placement of long dental implants and overdenture supported by RTX attachment system in people with Vertical Alveolar Bone Loss, run by Mansoura University at 1 site in Egypt.
Trial summary
This study was conducted to clinically and radiographically evaluate locator RTx attachments for two implant-supported mandibular overdenture using two loading protocols Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vertical Alveolar Bone Loss
- What is being tested?
- surgical placement of long dental implants and overdenture supported by RTX attachment system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2020to 20 Sep 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- adequate bone quantity [class III -V according to Cawood and Howell in the interforaminal area of the mandible to receive 2 implants (4×13 mm)
- adequate restorative space [12-15 mm from the mucosa of the mandibular ridge to the occlusal plane, Class I according to Ahuja and Cagna for RTX supported implant overdenture.
Who cannot join
- systemic diseases that contraindicate implant placement
- bone metabolic diseases as diabetes mellitus
- irradiation of the head and neck region
- chemotherapy within the past 3 years
- smoking habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of RTX Locator Attachments for Implant-supported Mandibular Complete Overdenture Using Two Loading Protocols
This study was conducted to clinically and radiographically evaluate locator RTx attachments for two implant-supported mandibular overdenture using two loading protocols
Read the detailed description
Thirty edentulous patients received two implants in the interformaninal region in the canine area . According to the loading protocol used for attaching mandibular overdenture, patients were randomly assigned into two equal groups. Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTx locator attachments using conventional loading protocol. Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol. Peri-implant tissue health [Plaque (PL) and (GI) gingival scores, pocket depth (PD), and crestal bone loss (CBL)] were evaluated immediately after denture insertion (T0), 6 (T6), and 12 (T12) months after insertion.
- Conditions
- Vertical Alveolar Bone Loss
- Being tested
- surgical placement of long dental implants, overdenture supported by RTX attachment system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical placement of long dental implantsProcedure or surgery
Two interforaminal implants were placed in the canine region
overdenture supported by RTX attachment systemDevice
Control group: Implants were loaded after three months by RTX supported overdenture study group: Implants were loaded after four weeks by RTX supported overdenture
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTx locator attachments using conventional loading protocol Receives: Procedure: surgical placement of long dental implants; Device: overdenture supported by RTX attachment system |
| Study group | Active comparator | Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol. Receives: Procedure: surgical placement of long dental implants; Device: overdenture supported by RTX attachment system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
evaluations of crestal bone loss in mm around implants by digital periapical radiography
Measured: one year
plaque score
evaluation of plaque accumulation around RTX attachments using scores.score 0; absence plaque , score 1; plaque only detected by a probe passing through the smooth marginal surface of the implant, score 2; plaque can be recognized by naked eye, and score 3; plenty of soft matter.
Measured: one year
gingival index
evaluation of gingival bleeding around RTX attachments using scores.0; no bleeding when a periodontal probe is passed along the mucosal margin, 1;isolated bleeding spots visible, 2; blood forms a confluent red line on the mucosal margin, 3;heavy or profuse bleeding.
Measured: one year
pocket depth
evaluation of pocket depth in mm around RTX attachments
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 posted22 Mar 2022
- Study start15 Jan 2020
- Primary completion15 Dec 2020
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertical Alveolar 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. Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTX locator attachments using conventional loading protocol. Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 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
- NCT05290376
- Sponsor's protocol ID
- A03110220
- Status last verified
- Dec 2021
- First submitted
- 15 Dec 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of RTX Locator Attachments for Implant-supported Mandibular Complete Overdenture Using Two Loading Protocols
- ClinicalTrials.gov ID
- NCT05290376
- Acronym / sponsor ID
- A03110220
- Conditions
- Vertical Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 22 Mar 2022 (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 clinically and radiographically evaluate locator RTx attachments for two implant-supported mandibular overdenture using two loading protocols
Detailed description
Thirty edentulous patients received two implants in the interformaninal region in the canine area . According to the loading protocol used for attaching mandibular overdenture, patients were randomly assigned into two equal groups. Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTx locator attachments using conventional loading protocol. Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol. Peri-implant tissue health [Plaque (PL) and (GI) gingival scores, pocket depth (PD), and crestal bone loss (CBL)] were evaluated immediately after denture insertion (T0), 6 (T6), and 12 (T12) months after insertion.
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. Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTX locator attachments using conventional loading protocol. Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: surgical placement of long dental implants, Device: overdenture supported by RTX attachment systemGroup I (control): patients who would be delivered mandibular implant overdenture retained by two RTx locator attachments using conventional loading protocol |
| Study group | Active comparator | Procedure: surgical placement of long dental implants, Device: overdenture supported by RTX attachment systemGroup II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- adequate bone quantity [class III -V according to Cawood and Howell in the interforaminal area of the mandible to receive 2 implants (4×13 mm)
- adequate restorative space [12-15 mm from the mucosa of the mandibular ridge to the occlusal plane, Class I according to Ahuja and Cagna for RTX supported implant overdenture.
Key exclusion criteria (5 listed)
- systemic diseases that contraindicate implant placement
- bone metabolic diseases as diabetes mellitus
- irradiation of the head and neck region
- chemotherapy within the past 3 years
- smoking habits.
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 long dental implantsTwo interforaminal implants were placed in the canine region | Procedure or surgery | Control group, Study group |
| overdenture supported by RTX attachment systemControl group: Implants were loaded after three months by RTX supported overdenture study group: Implants were loaded after four weeks by RTX supported overdenture | Device | Control group, Study group |
Primary outcome
Marginal bone loss
Time frame: one year
evaluations of crestal bone loss in mm around implants by digital periapical radiography
plaque score
Time frame: one year
evaluation of plaque accumulation around RTX attachments using scores.score 0; absence plaque , score 1; plaque only detected by a probe passing through the smooth marginal surface of the implant, score 2; plaque can be recognized by naked eye, and score 3; plenty of soft matter.
gingival index
Time frame: one year
evaluation of gingival bleeding around RTX attachments using scores.0; no bleeding when a periodontal probe is passed along the mucosal margin, 1;isolated bleeding spots visible, 2; blood forms a confluent red line on the mucosal margin, 3;heavy or profuse bleeding.
pocket depth
Time frame: one year
evaluation of pocket depth in mm around RTX attachments
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 22 Mar 2022.
- 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 surgical placement of long dental implants and overdenture supported by RTX attachment system in people with Vertical Alveolar 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 2 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 22 Mar 2022. 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?
Marginal bone loss (time frame: one year). The study lists 4 primary outcomes in all. 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 22 Mar 2022.