Effects Of Low Level Laser Therapy On Tooth Movement,Treatment Related Complications Of Gingivitis,Periodontitis And Pain In Fixed Orthodontic Patients

NCT04230096 | Completed DMC

• 1 other identifier: kishore kumar
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION Orthodontic treatment objectives are achieved through the movement of teeth with the application of an external physical force. It takes around 2 to 3 years to finish the treatment.The most common complications associated with orthodontic treatment are

1. 1.Pain
2. 2.Prolonged duration
3. 3.Gingival and Periodontal complications So orthodontists, clinicians and researchers are always looking for some non-invasive and reliable techniques to minimize the possibility of occurrence of these complications.

Conditions

Tooth Migration; Gingivitis; Pain; Periodontitis

Keywords

pain; complications; movement; orthodontic; duration

Outcome Measures

Primary Outcomes (1)

• Pain associated with tooth movement: numerical rating scale

  To study the analgesic effect of Low- Level Laser Therapy, numerical rating scale (NRS) will be used (Bertl, 2012). This scale ranges from 0 to 10 where 0 denotes no pain and 10 signify unbearable pain. NRS scale is valid, reliable and easier to be used by patients as compared to other similar scales like VAS (visual analogue scale) (Brunelli, 2010).

  A Performa to record the level of pain will be given to participants and advised to record the pain intensity for 7 days, experienced 2 hours after force application,as a primary outcome participants in experimental group may feel lesser pain.

Secondary Outcomes (5)

• Gingival index

  To take examinations on each orthodontic treatment visit after every three weeks till six months of all participants of both groups,may show improvement in experimental group

• Bleeding on Probing

  To take examinations on each orthodontic treatment visit after every three weeks till six months

• Clinical Attachment Loss

  To take examinations on each orthodontic treatment visit after every three weeks till six months

• Probing Depth

  To take examinations on each orthodontic treatment visit after every three weeks till six months

• Rate of tooth movement:

  To study the effect of Low- Level Laser Therapy on tooth movement the study models to access tooth movement will be taken in all visits from 0 to 6th visit.

Study Arms (2)

applied group

EXPERIMENTAL

low level laser therapy applied in one group

Device: low level laser therapy

controlled group

NO INTERVENTION

other group will be controlled in which low level laser will not be applied

Interventions

low level laser therapy DEVICE

apply low level laser therapy on buccal surface of maxillary jaw on anterior segment for three minutes at every three weeks in fixed orthodontic patients in their regular follow up visits

Also known as: LLLT

applied group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Selected patients will be Pakistani ethnic background.
• Age 18 to 30 years.
• Patients with class 1 with mild crowding (severity of malocclusion) according to little irregularity index to avoid individual variations. (Little, 1975)
• Patient with healthy periodontium with no any sign of gingival inflamation.
• Patients who indicated for orthodontic treatment with fixed appliances started with the conventional ligated brackets.
• Patients who will sign consent for participation in research and use of collected specimen/data for future reference.
• Patients who are able to read and understand English language because consent forms available only in language of English.
• Patients with ovoid arch form to compact with laser assisted tray.

You may not qualify if:

• Patients on medications which alter the gingival health e.g. Phenytoin (Dilantin), Cyclosporine A (Sandimmun), Nifedipine (Adalat), Corticosteroids, contraceptive pills.
• Patients on those medications which alter the bone metabolism or tooth movement e.g. NSAIDs, Corticosteroids, Bisphosphonates etc.
• Patients with following disorder: Diabetes Type 1 and 2, Osteoporosis, Platelet disorders, Vitamin C deficiency, vascular conditions, Leukemia, HIV infection, crohn's disease.
• Patients with pregnancy.
• Patients with parafunctional habits, TMJ dysfunction, craniofacial malformation, multiple missing teeth, impacted teeth except third molars, or periodontally compromised patients will be excluded from the study.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan Hospital for Women Karimabad A secondary Hospital ofAga khan university Hospital

Karachi, Sindh Pakistan, 75000, Pakistan

Location

Related Publications (6)

• Aihara N, Yamaguchi M, Kasai K. Low-energy irradiation stimulates formation of osteoclast-like cells via RANK expression in vitro. Lasers Med Sci. 2006 Apr;21(1):24-33. doi: 10.1007/s10103-005-0368-4. Epub 2006 Mar 28.

  PMID: 16568210 RESULT

• Hamdan AM. The relationship between patient, parent and clinician perceived need and normative orthodontic treatment need. Eur J Orthod. 2004 Jun;26(3):265-71. doi: 10.1093/ejo/26.3.265.

  PMID: 15222710 RESULT

• Jones ML, Chan C. Pain in the early stages of orthodontic treatment. J Clin Orthod. 1992 May;26(5):311-3. No abstract available.

  PMID: 1430181 RESULT

• Jones ML, Richmond S. Initial tooth movement: force application and pain--a relationship? Am J Orthod. 1985 Aug;88(2):111-6. doi: 10.1016/0002-9416(85)90234-9.

  PMID: 3861096 RESULT

• Lim HM, Lew KK, Tay DK. A clinical investigation of the efficacy of low level laser therapy in reducing orthodontic postadjustment pain. Am J Orthod Dentofacial Orthop. 1995 Dec;108(6):614-22. doi: 10.1016/s0889-5406(95)70007-2.

  PMID: 7503039 RESULT

• Qadri T, Miranda L, Tuner J, Gustafsson A. The short-term effects of low-level lasers as adjunct therapy in the treatment of periodontal inflammation. J Clin Periodontol. 2005 Jul;32(7):714-9. doi: 10.1111/j.1600-051X.2005.00749.x.

  PMID: 15966876 RESULT

MeSH Terms

Conditions

Gingivitis; Pain; Periodontitis; Tooth Migration

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: This will be an experimental; case controlled study

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: January 18, 2020
• Study Start: December 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)