NCT07374523

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Sep 2025Dec 2026

Study Start

First participant enrolled

September 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

January 20, 2026

Last Update Submit

April 23, 2026

Conditions

Implant Therapy

Keywords

implantclinical stabilityradiographic assessmentsoft tissue healthMelatoninimmediate implant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • post-operative pain (VAS)

    At 1, 3 and 7 days postoperatively

  • post-operative Edema

    At 1, 3 and 7 days postoperatively

  • Marginal bone loss

    Immediately postoperatively (baseline) 3 months postoperatively 6 months postoperatively

  • Bone density

    Immediately postoperatively (baseline) 3 months postoperatively 6 months postoperatively

Study Arms (2)

Melatonin gel

EXPERIMENTAL
Other: Melatonin gelOther: Control

control without melatonin gel

PLACEBO COMPARATOR
Other: Melatonin gelOther: Control

Interventions

Melatonin gelOTHER

the implant was placed with melatonin application (3mg Melatonin into 2ml of Hydroxyethyl Cellulose Gel 2%).

Melatonin gelcontrol without melatonin gel
ControlOTHER

the implant was placed without melatonin.

Melatonin gelcontrol without melatonin gel

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Suez Canal University

Ismailia, Egypt, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

January 28, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

EG(1)