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Application of Local Melatonin in Peri-implantitis

NCT06816277 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-11

No results posted yet for this study

Summary

A randomized clinical trial was carried out in patients affected by peri-implantitis with a follow-up of 60 days. Melatonin 1.9 mg or placebo was applied locally to the peri-implant defect after nonsurgical debridement.

To determine the effectiveness anti-inflammatory, osteogenic and antimicrobial properties were evaluated. The probing depth, bleeding index, plaque index, and interleukin-1β and 6 concentrations, peri-implant bone level and the bacterial strains were analyzed.

Conditions

  • Periimplantitis

Interventions

PROCEDURE

Desbridamiento de periimplantitis

The implant with the most severe involvement was selected, although the treatment was performed on all implants, to prevent patients with more affected implants from having greater statistical relevance. The peri-implant surgical treatment was performed under local infiltrative anesthesia with 4% articaine with 1:100,000 adrenaline. Debridement was performed using ultrasound with irrigation, complemented using curettes. Treatment with melatonin or placebo was applied through computer block randomization. To achieve blinding, a different code was assigned to the group applying 1.9 mg of melatonin (A) and to the control group (B) applying placebo (dextrinomaltose 2 mg) powder and the samples and records were coded. It was sutured with 4/0 monofilament in a pre-assembled 3/8 s

DRUG

Aplicación de melatonina

Treatment with melatonin or placebo was applied through computer block randomization. To achieve blinding, a different code was assigned to the group applying 1.9 mg of melatonin (A) and to the control group (B) applying placebo (dextrinomaltose 2 mg) powder and the samples and records were coded.

OTHER

Placebo application

Treatment with melatonin or placebo was applied through computer block randomization. To achieve blinding, a different code was assigned to the group applying 1.9 mg of melatonin (A) and to the control group (B) applying placebo (dextrinomaltose 2 mg) powder and the samples and records were coded.

Sponsors & Collaborators

  • Universidad Complutense de Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-07-15
Completion
2023-07-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06816277 on ClinicalTrials.gov