PeriimplantitisNCT06166446
Comparison of Denture Base Adaptation and Per-iimplant Tissue Health Between CAD and CAM Implant Overdenture
A study testing subtractive technique and additive technique in people with Periimplantitis, run by Mansoura University at 1 site in Egypt.
Trial summary
Background: Complete overdenture manufacturing has been greatly developed using computer-aided designing and computer-aided manufacturing (CAD-CAM) technology. Material and method: 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. Read more about this study
- Who is it for?
- Ages 58 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Periimplantitis
- What is being tested?
- subtractive technique and additive technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2022to 2 Feb 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 58 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- poor denture adaptation co-operative patients
Who cannot join
- metabolic diseases uncontrolled diabetes osteoporosis and hyperparathyroidism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Denture Base Adaptation and Per-implant Tissue Health Between CAD and CAM Implant Retained Complete Overdenture
Background: Complete overdenture manufacturing has been greatly developed using computer-aided designing and computer-aided manufacturing (CAD-CAM) technology.
Material and method: 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue and denture adaptation were evaluated using clinical parameters
Read the detailed description
Background: In recent years, complete overdenture manufacturing has been greatly developed using computer-aided designing and computer-aided manufacturing (CAD-CAM) technology. This clinical study compared the soft tissue health between CAD/CAM-milled and 3D-printed implants that retained complete overdentures.
Material and method: 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue was evaluated using clinical parameters including the gingival index, plaque index, bleeding index, and probing depth at the time of mandibular complete overdenture insertion (T0), six months (T6), and twelve months (T12) of denture use.
- Conditions
- Periimplantitis
- Being tested
- subtractive technique, additive technique
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subtractive techniqueDevice
The milled denture teeth are then bonded into the milled recesses using a special PMMA bonding system.
additive techniqueDevice
The denture teeth were printed as one unit using the same method with tooth resin (DENTCA Denture Tooth, Shade A2).
| Study group | Role | What they receive |
|---|---|---|
| a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture | Active comparator | patients received lower denture fabricated by milling technique Receives: Device: subtractive technique |
| 3rd printed mandibular overdenture and a maxillary acrylic conventional complete denture | Active comparator | The denture base was fabricated by adding the material layer by layer Receives: Device: additive technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Plaque Index
a calibrated pressure sensitive plastic periodontal probe, the distance between marginal border of the peri-implant mucosa and the tip of the probe was measured and considered as pocket depth
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start15 Jan 2022
- Primary completion25 Apr 2022
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriimplantitisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue was evaluated using clinical parameters including the gingival index, plaque index, bleeding index, and probing depth at the time of mandibular complete overdenture insertion (T0), six months (T6), and twelve months (T12) of denture use.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marwa Aboelez, Phd, Principal investigator, Mansoura UniversityRadwa Emera, Phd, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166446
- Sponsor's protocol ID
- A10080921
- Status last verified
- Nov 2023
- First submitted
- 3 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Emera RMK, Shady M, Alnajih MA. Comparison of retention and denture base adaptation between conventional and 3D-printed complete dentures. J Dent Res Dent Clin Dent Prospects. 2022 Summer;16(3):179-185. doi: 10.34172/joddd.2022.030. Epub 2022 Nov 15.
PubMed 36704186Elmanci TM, Mourad KE, Abdelsameaa SE, Aboelez MA, Emera RMK. Peri-implant soft tissue health and denture base adaptation of CAD/CAM milled versus 3D-printed implant-assisted mandibular overdentures: one-year randomized clinical trial. Sci Rep. 2026 Mar 13;16(1):9091. doi: 10.1038/s41598-026-40422-9.
PubMed 41826501
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Denture Base Adaptation and Per-implant Tissue Health Between CAD and CAM Implant Retained Complete Overdenture
- ClinicalTrials.gov ID
- NCT06166446
- Acronym / sponsor ID
- A10080921
- Conditions
- Periimplantitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 12 Dec 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.
Background: Complete overdenture manufacturing has been greatly developed using computer-aided designing and computer-aided manufacturing (CAD-CAM) technology.
Material and method: 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue and denture adaptation were evaluated using clinical parameters
Detailed description
Background: In recent years, complete overdenture manufacturing has been greatly developed using computer-aided designing and computer-aided manufacturing (CAD-CAM) technology. This clinical study compared the soft tissue health between CAD/CAM-milled and 3D-printed implants that retained complete overdentures.
Material and method: 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue was evaluated using clinical parameters including the gingival index, plaque index, bleeding index, and probing depth at the time of mandibular complete overdenture insertion (T0), six months (T6), and twelve months (T12) of denture use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue was evaluated using clinical parameters including the gingival index, plaque index, bleeding index, and probing depth at the time of mandibular complete overdenture insertion (T0), six months (T6), and twelve months (T12) of denture use.
| Arm | Type | Receives |
|---|---|---|
| a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture | Active comparator | Device: subtractive techniquepatients received lower denture fabricated by milling technique |
| 3rd printed mandibular overdenture and a maxillary acrylic conventional complete denture | Active comparator | Device: additive techniqueThe denture base was fabricated by adding the material layer by layer |
Who may qualify
- Ages
- 58 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- poor denture adaptation co-operative patients
Key exclusion criteria (1 listed)
- metabolic diseases uncontrolled diabetes osteoporosis and hyperparathyroidism.
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 |
|---|---|---|
| subtractive techniqueThe milled denture teeth are then bonded into the milled recesses using a special PMMA bonding system. | Device | a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture |
| additive techniqueThe denture teeth were printed as one unit using the same method with tooth resin (DENTCA Denture Tooth, Shade A2). | Device | 3rd printed mandibular overdenture and a maxillary acrylic conventional complete denture |
Primary outcome
Modified Plaque Index
Time frame: 12 months
a calibrated pressure sensitive plastic periodontal probe, the distance between marginal border of the peri-implant mucosa and the tip of the probe was measured and considered as pocket depth
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 21 Dec 2023.
- Background: PubMed 36704186Emera RMK, Shady M, Alnajih MA. Comparison of retention and denture base adaptation between conventional and 3D-printed complete dentures. J Dent Res Dent Clin Dent Prospects. 2022 Summer;16(3):179-185. doi: 10.34172/joddd.2022.030. Epub 2022 Nov 15.
- Derived from this study: PubMed 41826501Elmanci TM, Mourad KE, Abdelsameaa SE, Aboelez MA, Emera RMK. Peri-implant soft tissue health and denture base adaptation of CAD/CAM milled versus 3D-printed implant-assisted mandibular overdentures: one-year randomized clinical trial. Sci Rep. 2026 Mar 13;16(1):9091. doi: 10.1038/s41598-026-40422-9.
- 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.
Marwa Aboelez, Phd principal investigator
Mansoura University
Radwa Emera, Phd study director
Mansoura 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 subtractive technique and additive technique in people with Periimplantitis, 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 1 inclusion and 1 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 21 Dec 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?
Modified Plaque Index (time frame: 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 NCT06166446, which also lists 2 linked publications.
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 21 Dec 2023.