Effect of Topical Melatonin Application on Dental Implant Osseointegration and Marginal Bone Level

NCT04229719 | Unknown Phase 3 DMC

• 1 other identifier: U0004TGZ
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Melatonin (N-acetyl-5-methoxy-tryptamine) is an indoleamine synthesized and secreted by the pineal gland and other organs, such as the retina, bone marrow, and intestines in a circadian pattern. Some authors claimed that Melatonin induces bone formation, increase bone density, and bone implant contact. According to animal and human studies the melatonin can be used topically during implant placement to increase bone implant contact and reduce marginal bone loss. Purpose: The aim of this study was to evaluate the effect of the topical administration of melatonin on osseointegration of dental implants and in minimize marginal bone loss. Materials and Methods: Twenty single-piece endosseous implants (Dentium Co, Korea) will use to restore missing lower teeth from canine to first molar area. The study will be split-mouth technique, each patient serve as his own control (served into 2 groups), the study side (topical application of melatonin in the implant side), and the control side (no melatonin in the other implant side of the same patients).The primary and secondary stability of dental implant will be evaluated by periotest M device and measure bone level as baseline immediately after implant placement and after 6 months follow up by CBCT.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• Measuring marginal bone level

  measure crestal bone loss around dental implant using a cone-beam computed tomography (CBCT).

  6 months .

Secondary Outcomes (2)

• Measuring primary stability of the dental implant

  0 day.

• Measuring secondary stability of the dental implant

  6 months.

Study Arms (2)

Melatonin group

EXPERIMENTAL

Melatonin powder (N-Acetyl-5-methoxytryptamine) 1.2mg topical application in osteotomy site.

Drug: N-acetyl-5-methoxytryptamine

Control group

NO INTERVENTION

No drug intervention

Interventions

N-acetyl-5-methoxytryptamine DRUG

1.2 mg of melatonin powder will place in the osteotomy site before the insertion of the implant.

Also known as: Melatonin powder

Melatonin group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients have good oral hygiene.
• Patients were periodontally healthy.
• Patients had at least two missing teeth in the upper or lower jaw (canine to 1st molar area) indicated for the dental implant.

You may not qualify if:

• Patients with any systemic diseases that influence bone healing such as osteoporosis and diabetes mellitus.
• Fully edentulous.
• Patients who had parafunctional habits.
• Smokers.
• Patients who were not able to follow the treatment protocol.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry / University of Baghdad

Baghdad, 10047, Iraq

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Zaid M Yasser, B.D.S

CONTACT

07810994677; zaid.al.aboodu@gmail.com

Saif S Saliem, M.S.C

CONTACT

+9647901529484

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Third professional person apply melatonin powder.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor of Dental Surgery (master's student)

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 18, 2020
• Study Start: November 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: November 1, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)