The Effect of Melatonin Application Following Removal of Impacted Third Molar

Impacted Third Molar Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424875
• Other study ID #: Melatonin and 3rd molar
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2021
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Cobo-Vázquez C, Fernández-Tresguerres I, Ortega-Aranegui R, López-Quiles J. Effects of local melatonin application on post-extraction sockets after third molar surgery. A pilot study. Med Oral Patol Oral Cir Bucal. 2014 Nov 1;19(6):e628-33. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone density	The bone density within the extraction socket was measured using software of cone beam	6months
Secondary	Osteoprotegerin (OPG)	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	4weeks postoperatively
Secondary	pain sensation	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).	7 days postoperative
Secondary	swelling	a tape measure, from the tragus to the corner of the mouth.	7 days postoperative
Secondary	trismus	measuring the distance between incisal edges of upper and lower central incisor at maximal mouth	7days postoperative