- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06682559
Comparison Between Two Different Healing Abutments in Single Posterior Implants
August 2, 2025 updated by: Rania Elsayed, Alexandria University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Alexandria, Egypt
- Faculty of Dentistry, Alexandria University, Egypt
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prefabricated healing abutment with scan peg (Neoss implant system, Harrogate, England)
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
|
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
|
|
Active Comparator: Customized healing abutment
12 participants will receive single posterior implants by fully guided implant protocol followed by placement of custom healing abutment having concave emergence profile
|
12 participants will receive single posterior implants by fully guided implant protocol followed by placement of custom healing abutment having concave emergence profile
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mervat E Abdellah, Alexandria University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2024
Primary Completion (Actual)
May 1, 2025
Study Completion (Estimated)
October 1, 2025
Study Registration Dates
First Submitted
November 4, 2024
First Submitted That Met QC Criteria
November 8, 2024
First Posted (Actual)
November 12, 2024
Study Record Updates
Last Update Posted (Actual)
August 5, 2025
Last Update Submitted That Met QC Criteria
August 2, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 0991-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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