- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07780227
Laser Modification of Dental Implant Abutment Surfaces
August 19, 2026 updated by: Alexandria University
Impact of Surface Modification of Abutments of Dental Implants by Laser on Soft Tissue Seal (A Randomized Controlled Clinical Trial)
Introduction: Tight soft tissue integration to the dental implants is essential to achieve a successful outcome of dental implants.
Contamination by oral bacteria of the implant-mucosa interface can result in gingival recession, pocket formation, and bone resorption.
There are many surface modification strategies to reinforce the soft tissue seal to dental implants.
One of these strategies is laser technology.
The aim of this study is to evaluate the effect of laser-induced roughness of titanium surfaces of final abutments on the connective tissue seal to the dental implant.
Materials and Methods: Twenty-four pure titanium abutments of dental implants will be evaluated in this study.
The abutments will be divided into 2 groups: group A will be treated with ND: YAG laser, and group B will not be treated with a laser as a control group.
After 3 months, evaluation will be done by measuring peri-implant probing depth, modified gingival index, bleeding index, plaque index, and patient satisfaction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
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
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-
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Alexandria, Egypt
- Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
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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:
- An informed consent will be signed from all the volunteers and they will be informed with all the steps, risk and benefits regarding the study.
- Patients having osseointegrated implants ready to receive final abutment.
Exclusion Criteria:
- The presence of chronic systemic disease.
- Smoking of more than 10 cigarettes per day.
- Bruxism habits.
- Alcohol or drug abuse.
- Poor oral hygiene.
- Pregnancy
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
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will include twelve abutments which will be left machined (as received from the manufacturer) to serve as controls.
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Experimental: Study group
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This will include twelve titanium abutments treated by ND: YAG laser with an output power 4 W, representing 80mJ for a period of 5 seconds (20).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in peri-implant probing depth
Time Frame: up to 3 months
|
Desirable probing depths around dental implants are 2.5mm to 4mm.
Peri-implantitis is often defined by the incidence of peri-implant probing depth ≥ 5 mm associated with bleeding on probing
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up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in Modified gingival index (MGI)
Time Frame: up to 3 months
|
the scoring will be as follows: 0 = absence of inflammation,
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up to 3 months
|
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chaneg in Bleeding index (BI)
Time Frame: up to 3 months
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The Bleeding Index (modified Index of Saxton), will be performed by using a dental probe.
The probe will be engaged approximately 1 millimetre (mm) into the gingival crevice.
A moderate pressure will be used while sweeping.
The scoring system is as follows: 0 = no bleeding after 30 seconds, 1 = bleeding upon probing after 30 seconds, 2 = immediate bleeding observed
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up to 3 months
|
|
change in Plaque index
Time Frame: up to 3 months
|
0 = no plaque.
1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth.
3 = a band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth, 4= more than 1/3 but less than 2/3 of the tooth is covered with plaque , 5 indicated that more than 2/3 of the tooth surface is covered with plaque
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up to 3 months
|
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Patient satisfaction
Time Frame: up to 3 months
|
Patient satisfaction will be assessed using a visual analogue scale (VAS)
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up to 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
June 15, 2025
Primary Completion (Actual)
December 25, 2025
Study Completion (Actual)
December 30, 2025
Study Registration Dates
First Submitted
August 19, 2026
First Submitted That Met QC Criteria
August 19, 2026
First Posted (Actual)
August 21, 2026
Study Record Updates
Last Update Posted (Actual)
August 21, 2026
Last Update Submitted That Met QC Criteria
August 19, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1078-05/2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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