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OpenTrials
Completed

NCT Number: NCT04424875

The Effect of Melatonin Application Following Removal of Impacted Third Molar

In the present study, the main hypothesis hypothesizes that the local application of melatonin in the post-extraction socket produces favorable differences in the immediate postoperative period, as anti-inflammatory, analgesic, and early osteogenic regarding the natural healing process of the socket.

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Key information

Conditions

Impacted Third Molar Tooth

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18ys
  • no systemic disease
  • impacted mandibular third molar class II position B on Pell- Gregory classification

Exclusion criteria

  • history of metabolic or systemic diseases affecting bone or healing process,
  • local infection,
  • tobacco use,
  • oral contraceptive,
  • pregnancy and lactation
  • patients who had taken analgesics or anti-inflammatories for 1 week prior to enrollment in the study

Treatment and study plan

3 mg Melatonin

Drug

patients will remove impacted third molar and receive 3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%

Other names: melatonin group

Placebo

Drug

patients will remove impacted third molar and receive 2 ml hydroxyethyl cellulose gel 2%

Other names: cellulose group

Primary outcomes

  1. Bone density

    Time frame: 6months

    The bone density within the extraction socket was measured using software of cone beam

Secondary outcomes

  1. Osteoprotegerin (OPG)

    Time frame: 4weeks postoperatively

    Human Osteoprotegerin (OPG) ELISA Kit was used to detect OPG levels.The changes in OPG in the whole group in the predetermined period immediate postoperative , after 4 week,and 6months

  2. pain sensation

    Time frame: 7 days postoperative

    a visual analogue scale (VAS) of 10 units in combination with a graphic rating scale. On the VAS, the left most end represented the absence of pain (score 0) and the right most end indicated the most severe pain (score 10).

  3. swelling

    Time frame: 7 days postoperative

    a tape measure, from the tragus to the corner of the mouth.

  4. trismus

    Time frame: 7days postoperative

    measuring the distance between incisal edges of upper and lower central incisor at maximal mouth

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

Local Melatonin Application Following Removal of an Impacted Mandibular Third Molar: A Randomized Controlled Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
May 18, 2021

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.

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