Laser Modification of Dental Implant Abutment Surfaces
Impact of Surface Modification of Abutments of Dental Implants by Laser on Soft Tissue Seal (A Randomized Controlled Clinical Trial)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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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
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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change in peri-implant probing depth
Time Frame: up to 3 months
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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
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Secondary Outcome Measures
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
|
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change in Plaque index
Time Frame: up to 3 months
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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
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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
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 1078-05/2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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