DentalimplantNCT06401200
Radiographic and Clinical Evaluation In Bar
A study testing bar retained implant overdenture in people with Dental, run by Minia University at 1 site in Egypt.
Trial summary
the aim of this study was to assess the marginal bone loss and soft tissue outcomes of milled and selective laser melted cobalt chromium bar retaining implant mandibular overdenture. Materials and method: twenty completely edentulous patients received new conventional complete dentures. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Dental
- What is being tested?
- bar retained implant overdenture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2022to 5 Jan 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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- completely edentulous patient.
- age range (50-60) years old.
- adequate bone volume in canine area bilaterally to receive implant of 3.7 mm diameter and 13mm length verified by CBCT for all patients.
- sufficient inter arch space (13-14mm) to accommodate bar construction
- normal maxillo-mandibular relation-ship
- (Angel's class I)
- proper oral hygiene
Who cannot join
- patients with metabolic or systemic disease that may affect osseointegration.
- history of radiation therapy.
- history of bisphosphonate intake
- heavy smoking and bad habits as bruxism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Marginal Bone Loss and Soft Tissue Health Around Implants in Selective Laser Melted Versus Milled Cobalt Chromium Bar Retained Mandibular Overdenture:(Randomized Controlled Trial)
the aim of this study was to assess the marginal bone loss and soft tissue outcomes of milled and selective laser melted cobalt chromium bar retaining implant mandibular overdenture. Materials and method: twenty completely edentulous patients received new conventional complete dentures. Two implants were placed at mandibular canine areas, patients were randomly allocated into two equal groups: milled co-cr bar group and selective laser melted bar group. Marginal bone loss, modified plaque index (mPI), probing depth (PD) and modified gingival index (mGI) were evaluated at base line, 6 and 12 months follow up visits.
Read the detailed description
Materials and method: twenty completely edentulous patients received new conventional complete dentures. Two implants were placed at mandibular canine areas, patients were randomly allocated into two equal groups: milled co-cr bar group and selective laser melted bar group. Marginal bone loss, modified plaque index (mPI), probing depth (PD) and modified gingival index (mGI) were evaluated at base line, 6 and 12 months follow up visits.
- Conditions
- Dental
- Being tested
- bar retained implant overdenture
- Keywords
- SLM, Milled, Bar overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bar retained implant overdentureOther
Also called bar attachment implant mandibular overdenture
use of bar attachment in completely edentulous patient
| Study group | Role | What they receive |
|---|---|---|
| group 1: milled cobalt chromium bar | Active comparator | 10 completely edentulous patients received two implants at canine region bilaterally (3.7mm diameter- 13mm length), within two weeks after surgery (following early loading protocol), an open tray impression technique was made for bar construction which was designed according to randomization patient enrollment Receives: Other: bar retained implant overdenture |
| group 2: Selective laser melted cobalt chromium bar | Experimental | 10 completely edentulous patients received two implants at canine region bilaterally (3.7mm diameter- 13mm length), within two weeks after surgery (following early loading protocol), an open tray impression technique was made for bar construction which was designed according to randomization patient enrollment Receives: Other: bar retained implant overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Evaluation (Vertical Marginal bone loss in millimeters)
using periapical x-ray with parallel long cone technique from implant shoulder till bony crest
Measured: at 6 and 12 months
Secondary outcomes (3)
Probing depth in millimeters.
using sensitive pressure plastic probe in four sites mesial, distal, buccal and lingual
Measured: at 0,6 and 12 months
modified Plaque Index.
using Mombelli charting scale at four aspects (mesial, distal, buccal and lingual)
Measured: at 0,6 and 12 months follow up
modified Gingival Index
using Apsi charting scale at four sites (mesial, distal, buccal and lingual)
Measured: at base line, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start15 Nov 2022
- Primary completion27 Dec 2023
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DentalStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Abd El Moatty Abd El Monem, Minia University
- Investigators
- Eman A Asfahani, PHD, Study chair, Minia UniversityHussein A Elhady, PHD, Study chair, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401200
- Sponsor's protocol ID
- 636
- Other IDs
- Iman Adel Asfahani, Hussein Abd Elhady
- Acronym
- implant
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
El-Asfahani IA, Abd El-Moatty R, Mohamed GF, Hussein HA. Marginal bone loss and soft tissue health around two-implant mandibular overdenture retained with milled versus selective laser melted cobalt chromium bar: a randomized clinical trial. BMC Oral Health. 2024 Oct 4;24(1):1180. doi: 10.1186/s12903-024-04883-6.
PubMed 39367394
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Bone Loss and Soft Tissue Health Around Implants in Selective Laser Melted Versus Milled Cobalt Chromium Bar Retained Mandibular Overdenture:(Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT06401200
- Acronym / sponsor ID
- implant / 636
- Conditions
- Dental
- Keywords
- SLM, Milled, Bar overdenture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 6 May 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.
the aim of this study was to assess the marginal bone loss and soft tissue outcomes of milled and selective laser melted cobalt chromium bar retaining implant mandibular overdenture. Materials and method: twenty completely edentulous patients received new conventional complete dentures. Two implants were placed at mandibular canine areas, patients were randomly allocated into two equal groups: milled co-cr bar group and selective laser melted bar group. Marginal bone loss, modified plaque index (mPI), probing depth (PD) and modified gingival index (mGI) were evaluated at base line, 6 and 12 months follow up visits.
Detailed description
Materials and method: twenty completely edentulous patients received new conventional complete dentures. Two implants were placed at mandibular canine areas, patients were randomly allocated into two equal groups: milled co-cr bar group and selective laser melted bar group. Marginal bone loss, modified plaque index (mPI), probing depth (PD) and modified gingival index (mGI) were evaluated at base line, 6 and 12 months follow up visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1: milled cobalt chromium bar | Active comparator | Other: bar retained implant overdenture10 completely edentulous patients received two implants at canine region bilaterally (3.7mm diameter- 13mm length), within two weeks after surgery (following early loading protocol), an open tray impression technique was made for bar construction which was designed according to randomization patient enrollment |
| group 2: Selective laser melted cobalt chromium bar | Experimental | Other: bar retained implant overdenture10 completely edentulous patients received two implants at canine region bilaterally (3.7mm diameter- 13mm length), within two weeks after surgery (following early loading protocol), an open tray impression technique was made for bar construction which was designed according to randomization patient enrollment |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- completely edentulous patient.
- age range (50-60) years old.
- adequate bone volume in canine area bilaterally to receive implant of 3.7 mm diameter and 13mm length verified by CBCT for all patients.
- sufficient inter arch space (13-14mm) to accommodate bar construction
- normal maxillo-mandibular relation-ship
Key exclusion criteria (4 listed)
- patients with metabolic or systemic disease that may affect osseointegration.
- history of radiation therapy.
- history of bisphosphonate intake
- heavy smoking and bad habits as bruxism.
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 |
|---|---|---|
| bar retained implant overdentureAlso: bar attachment implant mandibular overdentureuse of bar attachment in completely edentulous patient | Other | group 1: milled cobalt chromium bar, group 2: Selective laser melted cobalt chromium bar |
Primary outcome
Radiographic Evaluation (Vertical Marginal bone loss in millimeters)
Time frame: at 6 and 12 months
using periapical x-ray with parallel long cone technique from implant shoulder till bony crest
3 secondary outcomes
Probing depth in millimeters.
Time frame: at 0,6 and 12 months
modified Plaque Index.
Time frame: at 0,6 and 12 months follow up
modified Gingival Index
Time frame: at base line, 6 and 12 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 9 May 2024.
- Derived from this study: PubMed 39367394El-Asfahani IA, Abd El-Moatty R, Mohamed GF, Hussein HA. Marginal bone loss and soft tissue health around two-implant mandibular overdenture retained with milled versus selective laser melted cobalt chromium bar: a randomized clinical trial. BMC Oral Health. 2024 Oct 4;24(1):1180. doi: 10.1186/s12903-024-04883-6.
- Individual participant dataSharing planned: Undecided
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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.
Eman A Asfahani, PHD study chair
Minia University
Hussein A Elhady, PHD study chair
Minia 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 bar retained implant overdenture in people with Dental, run by Minia 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 7 inclusion and 4 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 May 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?
Radiographic Evaluation (Vertical Marginal bone loss in millimeters) (time frame: at 6 and 12 months). 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 NCT06401200, which also lists 1 linked publication.
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 May 2024.