Dental Implants, Single-ToothNCT05402202
Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations
A study testing Healing abutment with scan peg (Neoss implant system, Harrogate, England) and Customized healing abutment in people with Dental Implants, Single-Tooth, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of this randomized clinical trial is to evaluate the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants, Single-Tooth
- What is being tested?
- Healing abutment with scan peg (Neoss implant system, Harrogate, England) and Customized healing abutment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2022to 1 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who are classified as ASA I or II physical status and require mandibular single implants (single missing mandibular posterior teeth) with:
- Adequate interarch and mesiodistal space.
- Proper bone height and width.
- Adequate zone of keratinized tissue (at least 2 mm)
Who cannot join
- Any systematic disease as uncontrolled diabetes mellitus or metabolic bone diseases
- A history of head and neck radiation treatment.
- Periodontal diseases.
- Poor oral hygiene (Silness-Löe plaque index score 2 and 3) (32)
- Parafunctional habits.
- Malocclusion.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this randomized clinical trial is to evaluate the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body
Read the detailed description
Evaluation of the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body
- Conditions
- Dental Implants, Single-Tooth
- Being tested
- Healing abutment with scan peg (Neoss implant system, Harrogate, England), Customized healing abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing abutment with scan peg (Neoss implant system, Harrogate, England)Other
12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of healing abutment with scan peg
Customized healing abutmentOther
12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of customized healing abutment fabricated by intraoral scanning by scan body
| Study group | Role | What they receive |
|---|---|---|
| Healing abutment with scan peg (Neoss implant system, Harrogate, England) | Experimental | 12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of healing abutment with scan peg Receives: Other: Healing abutment with scan peg (Neoss implant system, Harrogate, England) |
| Customized healing abutment | Active comparator | 12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of customized healing abutment Receives: Other: Customized healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scanning time (healing abutment-scan peg vs scan body)
The scanning time by intraoral scanner will be recorded in both groups
Measured: Through study completion, an average of 1 year
Quality of proximal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body
The proximal contacts will be evaluated with dental floss
- Open: an open contact will be reported if there is no resistance against floss
- Ideal: an ideal contact will be reported if there is some resistance to interproximal floss insertion.
- Tight: a tight contact will be reported if it prevents the passage of floss through the proximal contact point.
The percentage of proximal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later.
Measured: Through study completion, an average of 1 year
Quality of occlusal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body
An evaluation of occlusion will be executed with 2 layers of shim stock of 12µ.
- No adjustment: if the shimstock is held when the patient clenches and does not need any adjustment.
- Mild adjustment: If the shim stock is held after simple closure, the occlusal contact will be reported as heavy and received mild chairside adjustment.
- Major adjustment: If the crown is returned to the manufacturing technician, the adjustment is considered major.
- Out of occlusion: If the shim stock passes without resistance after clenching, an open contact will be reported.
The percentage of occlusal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later.
Measured: Through study completion, an average of 1 year
Evaluation of occlusion by digital occlusal analyzer
occlusal force of implant-supported restorations will be measured
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start10 May 2022
- Primary completion10 Nov 2023
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implants, Single-ToothStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Elsayed, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402202
- Sponsor's protocol ID
- IORG0008831
- Status last verified
- Feb 2025
- First submitted
- 30 May 2022
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations
- ClinicalTrials.gov ID
- NCT05402202
- Acronym / sponsor ID
- IORG0008831
- Conditions
- Dental Implants, Single-Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 2 Jun 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.
The aim of this randomized clinical trial is to evaluate the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body
Detailed description
Evaluation of the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healing abutment with scan peg (Neoss implant system, Harrogate, England) | Experimental | Other: Healing abutment with scan peg (Neoss implant system, Harrogate, England)12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of healing abutment with scan peg |
| Customized healing abutment | Active comparator | Other: Customized healing abutment12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of customized healing abutment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients who are classified as ASA I or II physical status and require mandibular single implants (single missing mandibular posterior teeth) with:
Key exclusion criteria (6 listed)
- Any systematic disease as uncontrolled diabetes mellitus or metabolic bone diseases
- A history of head and neck radiation treatment.
- Periodontal diseases.
- Poor oral hygiene (Silness-Löe plaque index score 2 and 3) (32)
- Parafunctional 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 |
|---|---|---|
| Healing abutment with scan peg (Neoss implant system, Harrogate, England)12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of healing abutment with scan peg | Other | Healing abutment with scan peg (Neoss implant system, Harrogate, England) |
| Customized healing abutment12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of customized healing abutment fabricated by intraoral scanning by scan body | Other | Customized healing abutment |
Primary outcome
Scanning time (healing abutment-scan peg vs scan body)
Time frame: Through study completion, an average of 1 year
The scanning time by intraoral scanner will be recorded in both groups
Quality of proximal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body
Time frame: Through study completion, an average of 1 year
The proximal contacts will be evaluated with dental floss 1. Open: an open contact will be reported if there is no resistance against floss 2. Ideal: an ideal contact will be reported if there is some resistance to interproximal floss insertion. 3. Tight: a tight contact will be reported if it prevents the passage of floss through the proximal contact point. The percentage of proximal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later.
Quality of occlusal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body
Time frame: Through study completion, an average of 1 year
An evaluation of occlusion will be executed with 2 layers of shim stock of 12µ. 1. No adjustment: if the shimstock is held when the patient clenches and does not need any adjustment. 2. Mild adjustment: If the shim stock is held after simple closure, the occlusal contact will be reported as heavy and received mild chairside adjustment. 3. Major adjustment: If the crown is returned to the manufacturing technician, the adjustment is considered major. 4. Out of occlusion: If the shim stock passes without resistance after clenching, an open contact will be reported. The percentage of occlusal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later.
Evaluation of occlusion by digital occlusal analyzer
Time frame: Through study completion, an average of 1 year
occlusal force of implant-supported restorations will be measured
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 25 Feb 2025.
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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 Healing abutment with scan peg (Neoss implant system, Harrogate, England) and Customized healing abutment in people with Dental Implants, Single-Tooth, run by Alexandria 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 4 inclusion and 6 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 25 Feb 2025. 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?
Scanning time (healing abutment-scan peg vs scan body) (time frame: Through study completion, an average of 1 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 25 Feb 2025.