Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03689998
Other study ID # per21085
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 30, 2019
Est. completion date May 30, 2021

Study information

Verified date January 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


Description:

Melatonin is chemically recognized as N-acetyl-5-methoxytryptamine. It is a compound occurring naturally in plants, microbes and animals. The circulating level of the melatonin hormone in animals shows interesting variations, by entertainment of variable biological functions in a daily cycle "circadian rhythm". Melatonin called hormone of night is secreted by the pineal gland, and its plasma levels concentration are 50 folds higher in night in comparison to daytime. A variety of peripheral cells play a role in production of melatonin such as epithelial cells, bone marrow cells, and lymphocytes. Though melatonin is a hormone, it does not act on a specific organ, it has several functions; stimulation of the synthesis of type I collagen fibers, regulation of the body temperature, sexual development, antioxidant scavenging and detoxifying free radicals thus inhibiting the process of bone resorption through interfering with the function of osteoclasts.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date May 30, 2021
Est. primary completion date January 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria 1. Age: 18-60. 2. Healthy patients 3. Non Smoker 4. Patients with adequate bone volume for immediate dental implant procedure. 5. Patients with absence of any periapical pathosis. Exclusion criteria: 1. Heavy smokers. 2. Systemic disease that contraindicates implant placement or surgical procedures. 3. No or poor patient's compliance. 4. Psychological problems. 5. Pathology at the site of intervention. 6. Pregnancy females. 7. Patient refuses to sign the informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
immediate implant placement
immediate implant placement in freshly extraction socket
Drug:
Melatonin
topical application of melatonin

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary implant stability measuring implant stability using ostell 6 months
Secondary Soft tissue healing measuring the soft tissue healing by likert scale which classify the healing in to 5 score ( score 0 ,1 , 2 , 3 , 4 ( 0 indicate complete healing & 4 indicate incomplete healing 10 days
Secondary Post operative pain measuring the post operative pain by visual analog scale from 1 to 10 10 days
See also
  Status Clinical Trial Phase
Completed NCT03691467 - the Effect of Topical Application of Hyaluronic Acid on Immediate Dental Implant Phase 4
Not yet recruiting NCT04449302 - Evaluation of Papilla Index Around Immediate Mandibular Molar Implants Using Customized Healing Abutment Versus Submerged Healing N/A
Not yet recruiting NCT03692026 - Assessment of Immediate Implant Stability When Adding Mixture of Hyaluronic Acid and Melatonin Phase 4
Completed NCT02864862 - Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation Phase 4
Completed NCT04343833 - Immediate Implants in the Aesthetic Zone N/A
Recruiting NCT06455436 - Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments N/A
Active, not recruiting NCT03183349 - Immediate Implant Placement With Platlet Rich Fibrin as Space Filling Material Versus the Use of Deprotienized Bovine Bone (Tutogen) in Maxillary Premolars. N/A
Not yet recruiting NCT03804177 - The Effect Of Hyaluronic Acid And Melatonin With Systemic Administration of Vitamin C On Implant Stability After Immediate Implant in Anterior Region Phase 4
Completed NCT05101941 - Immediate Dental Implant Placed in the Presence of Chronic Inflammatory Periapical Lesions N/A