The Effect of Melatonin Application Following Removal of Impacted Third Molar

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04424875

Enrollment

Registered

2020-06-11

Start date

2020-07-01

Completion date

2021-05-01

Last updated

2021-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impacted Third Molar Tooth

Keywords

impacted third molar, melatonine, bone healing

Brief summary

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.

Interventions

DRUG3 mg melatonin

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Bone density	6months	The bone density within the extraction socket was measured using software of cone beam

Secondary

Measure	Time frame	Description
Osteoprotegerin (OPG)	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
pain sensation	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).
swelling	7 days postoperative	a tape measure, from the tragus to the corner of the mouth.
trismus	7days postoperative	measuring the distance between incisal edges of upper and lower central incisor at maximal mouth

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026