Low Level Laser Therapy in Postsurgical Treatment of Grafted Sockets

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001013550
• Date of registration: 29/09/2015
• Prospective Registration: No
• Primary sponsor: Adriana Monea
• Public title: Low Level Laser Therapy in Postsurgical Treatment of Grafted Sockets
• Scientific title: Histological Evaluation of the Efficiency of Low Level Laser Therapy on Bone Regeneration in Grafted Tooth Sockets
• Date of first enrolment: 21/07/2014
• Target sample size: 50
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12615001013550.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;

Countries of recruitment

Romania

Contacts

• Name: Dr Gabriela Beresescu

• Name: Dr Adriana Monea

Key inclusion & exclusion criteria

Inclusion criteria: systemically healthy subjects, no chronic treatment for any systemic disease, no active infection present at the time of extraction, 5 wall-extraction/ wall defects, undergoing tooth extract surgery in which sockets grafted with bone graft material and covered with resorbable collagen dressing
Exclusion criteria: periapical lesions
immediate post-surgical complications such as loose membrane or loose bone graft material

Age minimum: 20 Years
Age maximum: 60 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Tooth extraction;Socket graft healing;
Tooth extraction
Socket graft healing

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention(s)

Autostatic laser device which patient self-administers at home, pointing at site of grafted socket, starting in day 14 after surgery
Low level laser therapy on the site of grafted sockets; 810nm, 20mW/square cm, 20 min per day, 21 consecutive days
Laser device composed of a comfortable flexible headset, lightweight, low profile, with a soft nose and earpice for individual comfort profile and array positioning to fit range of patients; and a handsfree operation controller. On this controller the doctor sets treatment protocol and the controller counts down time and treatment sessions for patients awareness

Primary Outcome(s)

x-ray evaluation of bone density of grafted tooth sockets[baseline, 60 days, 90 days & 120 days post-surgery]

Secondary Outcome(s)

time between extraction/socket graft and implant placement[60 days, 90 days & 120 days post-surgery; from time of extraction/socket graft to time of implant placement]

Histological evaluation of biopsies taken from grafted sockets by the time of implant placement: level of bone regeneration
[60 days, 90 days & 120 days post-surgery]

Secondary ID(s)

nil

Source(s) of Monetary Support

University of Medicine and Pharmacy Tirgu-Mures

Ethics review

Status: Approved
Approval date:
Contact:

Ethical Commitee Of University of Medicine and Pharmacy Tirgu-Mures