Application of Local Melatonin in Peri-implantitis

NCT06816277 | Completed

• 2 other identifiers: C.I. 19/313-E2019-000828-18
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

melatonin; periimplant disease; marginal bone loss; inflammation; treatment

Outcome Measures

Primary Outcomes (1)

• Probing depth

  The distance from the gingival margin to the bottom of the periodontal pocket was considered. The measurement was carried out in the four locations surrounding the implant, mesial, distal, lingual and vestibular. Additionally, the average of the four locations was presented.

  60 days

Secondary Outcomes (6)

• Plaque Index (Löe y Silness)

  60 days

• Bleeding Index (Löe y Silness)

  60 days

• Marginal bone loss

  60 days

• IL-1β concentration

  60 days

• IL-6 concentration

  60 days

Study Arms (2)

Melatonina

EXPERIMENTAL

El tratamiento periimplantario y el desbridamiento mecánico se realizarán en todos los casos bajo anestesia local convencional. El procedimiento seguirá la secuencia habitual en todos los casos. El acceso quirúrgico se hará a través de una incisión intrasulcular y lineal, y el desprendimiento de un colgajo mucoperiostéico. El tratamiento peri-implante se realizará con una punta de ultrasonido bajo irrigación, complementada con el uso de curetas si es necesario. Posteriormente, en los casos del grupo correspondiente, se aplicará melatonina (1,9 mg) a la cama periimplantacional. Suturado con seda monofilamento 4/0 en una aguja semicircular de 3/8 premontada. Después de 7 días, se revisará el proceso de curación y se eliminarán las suturas.

Procedure: Desbridamiento de periimplantitis; Drug: Aplicación de melatonina; Other: Placebo application

Placebo

PLACEBO COMPARATOR

The peri-implant treatment and mechanical debridement will be performed in all cases under conventional local anesthesia. The procedure will follow the usual sequence in all cases. Surgical access will be made through an intrasulcular and linear incision, and the detachment of a mucoperiosteal flap. The peri-implant treatment will be performed with an ultrasound tip under irrigation, complemented by the use of curettes if necessary. Subsequently, in the cases of the corresponding group, melatonin (1.9 mg) will be applied to the peri-implant bed. sutured with 4/0 monofilament silk on a pre-mounted 3/8 semicircular needle. After 7 days, the healing process will be reviewed and the sutures will be removed.

Procedure: Desbridamiento de periimplantitis; Drug: Aplicación de melatonina; Other: Placebo application

Interventions

Desbridamiento de periimplantitis PROCEDURE

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

Melatonina; Placebo

Aplicación de melatonina DRUG

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.

Melatonina; Placebo

Placebo application OTHER

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.

Melatonina; Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peri-implant disease was recruited according to the criteria of the 2017 World Workshop Classification of Periodontal and Peri-implant Diseases and Conditions.
• Indication for peri-implant surgical treatment.
• One or more fully erupted teeth.
• American Society of Anesthesiologists \[ASA\] Category I and II.
• No history or metabolic or systemic diseases affecting the bone or healing process.
• Agreed to sign informed consent.

You may not qualify if:

• Tobacco use \>25 cigarettes per day.
• Use of hormonal, anti-inflammatory, corticosteroid, immunosuppressant, analgesic, antidiabetic or antiresorptive medications on a regular or recent basis.
• Pregnant or lactating women.
• Those who refused to participate in the study or did not allow follow-up and sample collection.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Department of Clinical Specialities. Faculty of Dentistry. Complutense University of Madrid.

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Peri-Implantitis; Inflammation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Letter and number code randomized assigned
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two blinded groups

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: February 10, 2025
• Study Start: September 1, 2020
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: February 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available for five years.
• Access Criteria: Applicants must identify the purpose of the data request

Locations

ES (1)