- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07608523
Marginal Bone Level Around Dental Implants in Periodontitis Patients ((MBL))
May 20, 2026 updated by: Howida Sabry
Evaluation of Marginal Bone Level Around Dental Implants With Two Types of Surface Characteristics in Periodontitis Patients
This study evaluates and compares marginal bone level changes around dental implants with two different surface characteristics in patients with a history of periodontitis.
Participants will receive dental implants and will be followed up for one year to assess bone level changes around the implants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients with treated periodontitis who require dental implants will be divided into two groups based on implant surface type.
Marginal bone level will be assessed radiographically at baseline, then at 3 months,6 months, and 12 months after implant placement.
The study aims to determine whether implant surface characteristics influence marginal bone loss in periodontitis-susceptible patients over a one-year follow-up period.
Study Type
Interventional
Enrollment (Actual)
40
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
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt
- Faculty of Dental Medicine for Girls, Al-Azhar University
-
-
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
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
1 - Age ranged from 35 to 55 years old, with a history of periodontitis. 2. Presence of at least one edentulous space
3. Presence of adequate bone volume to place implants and achieves primary implant stability without the need for bone reconstructive approaches. 4. Absence of systemic diseases
Exclusion Criteria:
- 1-Presence of para-functional habits. 2-Chronic smokers or former smokers. 3-Pregnancy and lactation. 4-In addition to any patient who is not willing to follow our treatment protocol.
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: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I - Periodontitis SLA
15 periodontitis patients receiving SLA surface implants
|
Sandblasted large-grit corundum and acid-etched (SLA) surface dental implant
|
|
Experimental: Group II - Periodontitis Plasma
15 periodontitis patients receiving plasma spraying surface treated implants
|
Plasma spraying surface treated dental implant
|
|
Active Comparator: Group III - Healthy SLA
5 periodontally healthy patients receiving SLA surface implants
|
Sandblasted large-grit corundum and acid-etched (SLA) surface dental implant
|
|
Active Comparator: Group IV - Healthy Plasma
5 periodontally healthy patients receiving plasma spraying surface treated implants
|
Plasma spraying surface treated dental implant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal Bone Level
Time Frame: Baseline, 3 months, 6 months, and 12 months after implant placement
|
Radiographic assessment of marginal bone level changes around dental implants measured in millimeters using Cone Beam Computed Tomography (CBCT)
|
Baseline, 3 months, 6 months, and 12 months after implant placement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Probing Depth
Time Frame: Baseline, 3 months, 6 months, and 12 months
|
probing depth measured in millimeters around implants
|
Baseline, 3 months, 6 months, and 12 months
|
|
Gingival Index
Time Frame: Baseline, 3 months, 6 months, and 12 months
|
Assessment of gingival inflammation around dental implants
|
Baseline, 3 months, 6 months, and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Osama Sayed EL-Shall, Professor, Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egypt
- Study Director: Lobna Mohamed Abd-ELaziz, Associate Professor, Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egypt
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)
April 30, 2023
Primary Completion (Actual)
April 30, 2025
Study Completion (Actual)
April 30, 2026
Study Registration Dates
First Submitted
May 20, 2026
First Submitted That Met QC Criteria
May 20, 2026
First Posted (Actual)
May 27, 2026
Study Record Updates
Last Update Posted (Actual)
May 27, 2026
Last Update Submitted That Met QC Criteria
May 20, 2026
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZHAR-OMPDR_103_2i-2023
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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