Evaluation of Melatonin Application of Immediate Dental Implant

NCT03689998 | Completed Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: per21085
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The presence of periapical pathology, the absence of kera¬tinized tissue and lack of complete soft tissue closure over the extraction socket have been reported a drawbacks of immediate implant placement . As mentioned before the presence of periapical pathology is one of the limitation of immediate implant placement, melatonin has an action against Gram-positive and Gram-negative microorganisms with a higher efficacy on the latter; it also showed efficacy against different strains of antibiotic-resistant bacteria. Melatonin was found to be effective in several cases as an anxiolytic and analgesic agent. It also reduce inflammatory pain by blocking the production of nitric oxid Also the lack of complete soft tissue closure over the extraction socket is one of the drawbacks of immediate implant placement; melatonin induces the production of interleukin-1, tumor necrosis factor (TNF)-α and transforming growth factor (TGF). In addition, melatonin is an immunomodulator and a neuroendocrine hormone, and stimulates both monocyte cytokine and fibroblast proliferation, which influence angiogenesis and wound healing.. As the initial implant stability is one of the criteria of implant success, Melatonin was found to increase new cortical bone width and length during the early stages (15 and 30 days), and it also promoted early cell differentiation. Melatonin acted on the bone as a local growth factor .

Conditions

Immediate Dental Implant

Keywords

immediate implant; melatonin; atrumatic extraction

Outcome Measures

Primary Outcomes (1)

• implant stability

  measuring implant stability using ostell

  6 months

Secondary Outcomes (2)

• Soft tissue healing

  10 days

• Post operative pain

  10 days

Study Arms (2)

implant placement with melatonine

EXPERIMENTAL

immediate implant placement with melatonine

Device: immediate implant placement; Drug: Melatonin

immediate implant placement alone

ACTIVE COMPARATOR

immediate implant placement alone

Device: immediate implant placement

Interventions

immediate implant placement DEVICE

immediate implant placement in freshly extraction socket

Also known as: post extraction dental implant

immediate implant placement alone; implant placement with melatonine

Melatonin DRUG

topical application of melatonin

implant placement with melatonine

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pt. eligible for implant placement after 18 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-60.
• Healthy patients
• Non Smoker
• Patients with adequate bone volume for immediate dental implant procedure.
• Patients with absence of any periapical pathosis.

You may not qualify if:

• Heavy smokers.
• Systemic disease that contraindicates implant placement or surgical procedures.
• No or poor patient's compliance.
• Psychological problems.
• Pathology at the site of intervention.
• Pregnancy females.
• Patient refuses to sign the informed consent.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

• El-Gammal MY, Salem AS, Anees MM, Tawfik MA. Clinical and Radiographic Evaluation of Immediate Loaded Dental Implants With Local Application of Melatonin: A Preliminary Randomized Controlled Clinical Trial. J Oral Implantol. 2016 Apr;42(2):119-25. doi: 10.1563/aaid-joi-D-14-00277. Epub 2015 Jun 23.

  PMID: 26103559 BACKGROUND

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mona Shoeib, Phd

  Cairo University

  STUDY CHAIR

• Mona Darhous, Phd

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate lecturer

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 1, 2018
• Study Start: September 30, 2019
• Primary Completion: January 12, 2021
• Study Completion: May 30, 2021
• Last Updated: June 8, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)