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NCT Number: NCT06814535

A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin on the Relief of Jaw Muscles Myofascial Pain

This study aims at comparing the effect of trigger points injection of platelet rich plasma and botulinum toxin a on the relief of jaw muscles Myofascial pain .

The 1st group includes 20 patients who are supposed to receive 5 units of botulinum toxin A per trigger point in masseter and/or temporalis muscles.

The 2nd group will receive ,5 ml of PRP per trigger point in masseter and/or temporalis muscles.

The 3rd group will receive .5 ml of physiologic saline per each trigger point in masseter and/or temporalis muscles.

The 1st follow up session will be after 1 week then 1 month then 3 months . The patients are advised to limit excessive Mouth opening, yawning or singing. And when pain episode , theta re advised to take only paracetamol as analgesic drug .

At the follow up sessions ، measuring the interincisal opening , pressure pain threshold using algometer , VAS to measure the intensity of pain , Likert scale , current pain intensity, worst pain intensity and the need to take analgesics in Numbers.

Then comparing the results of these groups to end in rejecting the null hypothesis which says there's an equivalence between the 3 types of injected solutions or accepting it .

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Key information

Conditions

Patients with Jaw Muscles Myofascial Pain

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of dentistry Cairo University

Giza, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient with myofascial trigger points in masseter or temporalis previously ----*identified by manual palpation.
  • 18 years or More "Willingness to follow instructions.

Exclusion criteria

  • therapeutic intervention for myofascial pain in the last view months such as taking medications for pain control or wearing an occlusal splint.
  • Clinical conditions as pregnancy
  • Medical problems that will interfere with the procedure as bleeding disorders.
  • Cognitive impairment or present inadequate cooperation.

Treatment and study plan

Botulinum Toxin A / Botulinum Toxin A

Drug

Botulinum toxin type A

Platelet rich plasma

Drug

Plasma that contains concentrated platelets

Saline -- placebo comparator

Drug

Physiological saline .9 %

Primary outcomes

  1. Pressure pain threshold

    Time frame: 3 months

    The amount of force per kilogram needed to induce pain in patients with myofascial pain at the trigger point..

    Will be measured using the algometer which presses on the trigger point to induce pain by force measured in kilograms/cm2 If the reading increased among the treatment visits , this means better outcome and decreased pain intensity with effectiveness of the treatment

  2. Current pain intensity

    Time frame: 3 months

    The amount of pain on VAS at the time of examination from 0-10 With 0 no pain which increases to reach 10 ( the highest pain intensity).. Decrease in pain intensity means better outcome

  3. Worst pain intensity

    Time frame: 3 months

    The worst pain the patient had suffered from on the previous duration. Using visual analogue scale from (0-10) with 0 least pain and 10 worst pain .

    Decrease in pain intensity means better outcome

Secondary outcomes

  1. Inter incisal opening

    Time frame: 3 months

    The measurement in millimeters of the distance between the incisal edge of the upper incisor and the lower incisor Using calibers to measure the effect of myofascial pain on decreasing muscle spasm and the effectiveness of the treatment by time.

    Increased degree of mouth opening meaning the muscles had relaxed and trigger points released

  2. Patient satisfaction

    Time frame: 3 months

    Will be measured by Likert scale by faces to indicate whether the treatment was satisfactory to the patient or not and to which degree .it affected their quality of life

  3. The need for analgesics

    Time frame: 3 months

    The patient will count how many Paracetamol tabs he took at the time from the last visit till now.

    With decreased amount of analgesics taken between the visits means better outcome

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin a on the Relief of Jaw Muscles Myofascial Pain

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.