Evaluation of the Effect of Low Level Laser Therapy on Crestal Bone Changes and Secondary Stability Around Delayed Implant
" EVALUATION OF LOW INTENSITY LASER BIOMODULATORY EFFECT ON CRESTAL BONE CHANGES AROUND DELAYED IMPLANTS " A Randomized Controlled Clinical Trial
1 other identifier
interventional
24
1 country
1
Brief Summary
Although implant survival and success rates are prominent, there is still progress to be made in both survival and success rates, as well as in improving implant stability at implant placement in order to accomplish osseo-integration without significantly reducing peri-implant marginal bone. Low-level laser therapy (LLLT) has been postulated in studies looking into enhancing implant stability. Understanding the effect of LLLT on bone remodeling is crucial to knowing whether LLLT will enhance implant-bone interaction. LLLT prompts vascularization of the bone defect site and also stimulates osteoblasts, which can facilitate recovery of hard tissue. In addition, it has been recently reported that LLLT has positive effects in ossification and osseo-integration of dental implants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
October 29, 2024
CompletedFirst Posted
Study publicly available on registry
October 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedOctober 30, 2024
October 1, 2024
1.2 years
October 29, 2024
October 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Radiographic evaluation of crestal bone changes
3 months
Secondary Outcomes (1)
Evaluation of the secondary implant stability using implant stability quotient ( ISQ ) in response to LLLT.
3 months
Study Arms (2)
Study group
ACTIVE COMPARATORControl group
PLACEBO COMPARATORInterventions
Laser biomodulation with low level laser therapy around delayed implant
Eligibility Criteria
You may qualify if:
- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire (18).
- Both genders. 3- Age from 20 -50 years old. 4- History of extraction\< 6 months. 5- Site specific upper esthetic zone from right second premolar to left second premolar.
You may not qualify if:
- Patients taking drugs affecting bone metabolism for the past six months. eg. cyclosporine, methotrexate, synthetic retinoids
- Smokers
- Pregnancy and lactation
- Patients with periodontal or periapical infections.
- Vertical and horizontal root fracture
- Mentally retarded Patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lina Amr Talaatlead
Study Sites (1)
Ain shams university
Cairo, 4531, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lina Amr Elsayed
Ain Shams University
- PRINCIPAL INVESTIGATOR
Lina Amr Elsayed, Master candidate
Ain Shams University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- BDS, periodontology and implantology, Ain shams university Clinical demonstrator oral medicine, periodontology horus university
Study Record Dates
First Submitted
October 29, 2024
First Posted
October 30, 2024
Study Start
March 1, 2023
Primary Completion
May 1, 2024
Study Completion
December 1, 2024
Last Updated
October 30, 2024
Record last verified: 2024-10