EFFECT OF LOW-LEVEL LASER THERAPY ON STABILITY OF DENTAL IMPLANTS PLACED IN A FRESH EXTRACTED SOCKET

NCT06148064 | Completed

• 1 other identifier: #2/3/2023
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study was to evaluate the effect of low-level laser therapy (LLLT) (660nm laser diode 0.5W) on implant stability and crestal bone loss in implants inserted in freshly extracted sockets augmented by Collaplug in the jumping gap.

Conditions

Dental Implant Stability

Outcome Measures

Primary Outcomes (2)

• Implant stability

  Implant stability was measured by OSSTELL at 4 different levels (buccal, lingual, mesial, and distal). Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. Higher levels indicate greater stability.

  up to 3 months

• Crestal bone loss

  Crestal bone loss was assessed using cone beam computed tomography (CBCT) by measuring the distance from the bone crest to the implant apex from mesial, distal, lingual and buccal aspects intraoperatively. Crestal bone loss up to 1.5 mm is considered a normal early finding through the first year after implant placement.

  up to 3 months

Study Arms (2)

Collaplug application with low level laser application.

EXPERIMENTAL

Other: Collaplug with low level laser

Collaplug application

ACTIVE COMPARATOR

Other: Collaplug

Interventions

Collaplug with low level laser OTHER

Immediate implant placement with applying a collaplug material in the jumping gap followed by low level laser application using Siro laser (660 nm, avg. power density: 0.5-WATT) circular spot diameter and area: 0.71 cm/0.4cm2) applied in six points in contact mode with peri-implant soft tissue (1.23 minutes in each point of application; dose per point 11 J) before bone perforation and after suturing.

Collaplug application with low level laser application.

Collaplug OTHER

Implant of suitable diameter and height was placed in the fresh extracted socket immediately after extraction and the jumping gap was augmented by the collaplug followed by healing abutment placement.

Collaplug application

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Any non-restorable hopeless tooth: badly decayed tooth that cannot be restored. Tooth with failed endodontic treatment and tooth with longitudinal fracture.
• Type I post-extraction sockets with all bony walls intact.
• No signs of active periodontal disease in the selected tooth.

You may not qualify if:

• The presence of any systemic disease that could complicate bone or soft tissue healing after immediate implant placement.
• The presence of acute periapical infection.
• The presence of any local factor that may interfere with extraction as tooth ankyloses.
• Subjects who had undergone therapeutical radiation.
• Patients who had been subjected to or who were under bisphosphonate therapy

Sponsors & Collaborators

• Nourhan M.Aly: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Study Officials

• Nermine A Elnakib, BDS

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Maha R Talaab, PhD

  Alexandria University

  STUDY CHAIR

• Nayrouz A Metwally, PhD

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 28, 2023
• Study Start: September 7, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 8, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

EG (1)