Dental ImplantsNCT06682559
Comparison Between Two Different Healing Abutments in Single Posterior Implants
A study testing Prefabricated healing abutment with scan peg and Customized healing abutment in people with Dental Implants and 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 volumetric analysis of peri-implant soft tissues after 3 months of the use of a prefabricated healing abutment with scan peg in comparison to customized healing abutment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants, Dental Implants, Single-tooth
- What is being tested?
- Prefabricated healing abutment with scan peg 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
- 1 Nov 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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:
- 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
- Pregnancy and Lactation
- A history of head and neck radiation treatment.
- Chronic periodontal diseases.
- Poor oral hygiene (Silness-Löe plaque index score 2 and 3)
- Parafunctional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Healing Abutments in Single Posterior Implants: A Randomized Clinical Trial
The aim of this randomized clinical trial is to evaluate the volumetric analysis of peri-implant soft tissues after 3 months of the use of a prefabricated healing abutment with scan peg in comparison to customized healing abutment.
Read the detailed description
Volumetric analysis of peri-implant soft tissues after 3 months of the use of a prefabricated healing abutment with scan peg with convex emergence profile in comparison to customized healing abutment with concave emergence profile.
- Conditions
- Dental Implants, Dental Implants, Single-tooth
- Being tested
- Prefabricated healing abutment with scan peg, Customized healing abutment
- Keywords
- Dental implants, single missing posterior teeth, peri-implant soft tissues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefabricated healing abutment with scan pegOther
12 participants will receive single posterior implants by fully guided implant protocol followed by placement of prefabricated healing abutment with scan peg having convex emergence profile
Customized healing abutmentOther
12 participants will receive single posterior implants by fully guided implant protocol followed by placement of custom healing abutment having concave emergence profile
| Study group | Role | What they receive |
|---|---|---|
| Prefabricated healing abutment with scan peg (Neoss implant system, Harrogate, England) | Experimental | 12 participants will receive single posterior implants by fully guided implant protocol followed by placement of prefabricated healing abutment with scan peg having convex emergence profile Receives: Other: Prefabricated healing abutment with scan peg |
| Customized healing abutment | Active comparator | 12 participants will receive single posterior implants by fully guided implant protocol followed by placement of custom healing abutment having concave emergence profile Receives: Other: Customized healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of peri-implant soft tissues volume
Each participant will undergo volumetric analysis of peri-implant soft tissues after 3 months healing either after using prefabricated healing abutment with scan peg in comparison to customized healing abutment using a 3D meteorology software (GOM inspect). It will be measured in millimeter cube
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Nov 2024
- Primary completion1 May 2025
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Elsayed, Alexandria University
- Investigators
- Mervat E Abdellah, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682559
- Sponsor's protocol ID
- 0991-10
- Status last verified
- Aug 2025
- First submitted
- 4 Nov 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Healing Abutments in Single Posterior Implants: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06682559
- Acronym / sponsor ID
- 0991-10
- Conditions
- Dental Implants, Dental Implants, Single-tooth
- Keywords
- Dental implants, single missing posterior teeth, peri-implant soft tissues
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 12 Nov 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 randomized clinical trial is to evaluate the volumetric analysis of peri-implant soft tissues after 3 months of the use of a prefabricated healing abutment with scan peg in comparison to customized healing abutment.
Detailed description
Volumetric analysis of peri-implant soft tissues after 3 months of the use of a prefabricated healing abutment with scan peg with convex emergence profile in comparison to customized healing abutment with concave emergence profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prefabricated healing abutment with scan peg (Neoss implant system, Harrogate, England) | Experimental | Other: Prefabricated healing abutment with scan peg12 participants will receive single posterior implants by fully guided implant protocol followed by placement of prefabricated healing abutment with scan peg having convex emergence profile |
| Customized healing abutment | Active comparator | Other: Customized healing abutment12 participants will receive single posterior implants by fully guided implant protocol followed by placement of custom healing abutment having concave emergence profile |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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
- Pregnancy and Lactation
- A history of head and neck radiation treatment.
- Chronic periodontal diseases.
- Poor oral hygiene (Silness-Löe plaque index score 2 and 3)
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 |
|---|---|---|
| Prefabricated healing abutment with scan peg12 participants will receive single posterior implants by fully guided implant protocol followed by placement of prefabricated healing abutment with scan peg having convex emergence profile | Other | Prefabricated healing abutment with scan peg (Neoss implant system, Harrogate, England) |
| Customized healing abutment12 participants will receive single posterior implants by fully guided implant protocol followed by placement of custom healing abutment having concave emergence profile | Other | Customized healing abutment |
Primary outcome
Measurement of peri-implant soft tissues volume
Time frame: 3 months
Each participant will undergo volumetric analysis of peri-implant soft tissues after 3 months healing either after using prefabricated healing abutment with scan peg in comparison to customized healing abutment using a 3D meteorology software (GOM inspect). It will be measured in millimeter cube
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- 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.
Mervat E Abdellah study director
Alexandria 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 Prefabricated healing abutment with scan peg and Customized healing abutment in people with Dental Implants and 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 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
Measurement of peri-implant soft tissues volume (time frame: 3 months). 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 5 Aug 2025.