NCT06666062

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

October 29, 2024

Last Update Submit

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 COMPARATOR
Other: implant placement and low level laser therapy

Control group

PLACEBO COMPARATOR
Procedure: implant placement

Interventions

Laser biomodulation with low level laser therapy around delayed implant

Study group

Delayed implant placement restoring missed tooth

Control group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Ain shams university

Cairo, 4531, Egypt

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Lina Amr Elsayed

    Ain Shams University

    PRINCIPAL INVESTIGATOR
  • Lina Amr Elsayed, Master candidate

    Ain Shams University

    PRINCIPAL INVESTIGATOR

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

Locations