Clinical and Radiographic Evaluation of Local Melatonin Application on Osseointegration of Immediate Mandibular Implants

Clinical and Radiographic Evaluation of Local Application of Melatonin on Osseointegration of Immediate Dental Implants for Mandibular Single Rooted Teeth: A Randomized Controlled Study

Clinical and Radiographic Evaluation of Local Application of Melatonin on Osseointegration of Immediate Dental Implants for Mandibular Single Rooted Teeth:

A Randomized Controlled Study

Study Overview

• Status: Active, not recruiting
• Conditions: Implant Therapy
• Intervention / Treatment: Other: Melatonin gel; Other: Control

Detailed Description

Dental implant is a treatment option that offers great functional and biologic advantages alongside noticeable long-term success outcomes with survival rates exceeding 95% . Delayed implant placement has been widely and successfully used for replacing missing teeth However, there are some challenges faced with delayed implant placement protocol due to the postextraction alveolar ridge resorption in buccolingual and apicocoronal directions .

The percentage of the post-extraction horizontal and vertical dimensional changes are 29-63% and 11-22% respectively . This is attributed to the disruption of vascular supply due to damage of periodontal ligament leading to pronounced bundle bone resorption . This pronounced post-extraction bone resorption usually leads to functional challenges and the need for augmentation procedures . In order to avoid such challenges, immediate post-extraction implant placement concept was introduced to avoid the bone resorption following tooth extraction and to reduce treatment time . Immediate implant placement showed a high overall implant placement rate reaching 97.1% as reported in the systematic review and 94.9% in the meta-analysis

Although immediate implant placement is effective in preservation of the alveolar bone dimensions but it fails to completely prevent the postextraction dimensional changes . Therefore, attempts were done regarding placement of various biomaterials in the peri-implant gap to increase the immediate implant stability and to minimize or even prevent the post-extraction bone dimensional changes if possible. Multiple materials were successfully used such as bone grafting materials like xenografts , autogenous graftsin addition to the application of bone morphogenetic proteins (BMPs), platelet rich fibrin (PRF) .

Melatonin (MLT) among these agents which are of a great interest for the recent researches whether in the medical or dental fields due to their confirmed physiological and structural functions, their biocompatibility and non-antigenic properties .

MLT is a natural hormone with powerful antioxidant properties, released mainly the pineal gland . It is successfully used in various conditions as sleep disorders, cardiovascular, chronic inflammatory diseases and parkinsonism

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Egypt
    • Ismailia, Egypt, Egypt
      • Faculty of Dentistry Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients aged between 21 and 60 years.
2. Good general health (ASA I).
3. Non-smokers or light smokers (<10 cigarettes/day).
4. Presence of a single non-restorable mandibular tooth indicated for extraction (incisor, canine, or premolar).
5. Adequate bone volume to receive a dental implant.
6. Patients with good oral hygiene.

Exclusion Criteria:

1. Medically compromised patients (e.g., uncontrolled diabetes, immunosuppressive therapy, bisphosphonate use)
2. Pregnant and lactating women.
3. Active periodontal disease at the implant site.
4. Acute infection at the extraction site (abscess or sinus tract).
5. Severe parafunctional habits (e.g., bruxism, clenching).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Melatonin gel	Other: Melatonin gel; the implant was placed with melatonin application (3mg Melatonin into 2ml of Hydroxyethyl Cellulose Gel 2%).; Other: Control; the implant was placed without melatonin.
Placebo Comparator: control without melatonin gel	Other: Melatonin gel; the implant was placed with melatonin application (3mg Melatonin into 2ml of Hydroxyethyl Cellulose Gel 2%).; Other: Control; the implant was placed without melatonin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability (ISQ)	Implant stability will be assessed using resonance frequency analysis and recorded as Implant Stability Quotient (ISQ) values on a scale from 1 to 100, where higher values indicate greater implant stability. ISQ values ≥70 indicate high stability; values 55-69 indicate moderate stability requiring monitoring; and values <55 indicate low stability.	Immediately postoperatively and at 6months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative pain (VAS)	Postoperative pain assessed using visual analogue scale (VAS) Visual Analog Scale (VAS) for Pain, Grades: 0 - No pain 1-3 - Mild pain (nagging, annoying, but not interfering with activities) 4-6 - Moderate pain (interferes significantly with activities) 7-10 - Severe pain (disabling, unable to perform activities)	At 1, 3 and 7 days postoperatively
post-operative Edema	Post-operative Edema Scale (Grade 0-3) Grades: Grade 0: No edema observed Grade 1: Intraoral edema only Grade 2: Extraoral edema Grade 3: Diffuse edema involving both intraoral and extraoral areas	At 1, 3 and 7 days postoperatively
Marginal bone loss	Marginal bone loss: Marginal bone loss will be measured using DIGORA software (Soredex, Helsinki, Finland) by calculating the vertical distance (in millimeters) from the implant shoulder/platform to the first bone-to-implant contact on the mesial and distal aspects.	Immediately postoperatively (baseline) 3 months postoperatively 6 months postoperatively
Bone density	Peri-implant bone density will be assessed using DIGORA software (Soredex, Helsinki, Finland) by calculating mean gray scale values within a standardized region of interest (ROI) adjacent to the implant, where higher gray scale values indicate greater bone density.	Immediately postoperatively (baseline) 3 months postoperatively 6 months postoperatively

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Melatonin; implant; immediate implant; radiographic assessment; clinical stability; soft tissue health
• Other Study ID Numbers: 1008/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No