The effect of using melatonin hormone locally along with xenograft on bone regeneration and improving the quality of soft tissue in the extracted tooth area
Effect of locally applied melatonin combined with xenograft on bone regeneration and improving attached gingiva thickness in the post-extraction dental socket.
Design
This is a Split-Mouth clinical trial on twenty patients. Randomization is performed using Random Blocks with the goal of allocating the treatment method to the two sides of the mouth (Intervention or Control) to prevent the allocation from being predicted by the researcher. Valid software tools (such as Random.org or SPSS) .
Settings and conduct
This study uses a Split-mouth design. The intervention side in patients with extracted teeth receives a xenograft plus topical melatonin, while the control side receives only the xenograft. Biopsies are taken from both sides after two months, prior to implant placement, by a specialist blinded to the intervention. The study is Double-blind: the patient and implant surgeon are unaware of the melatonin application, with only the researcher knowing the details.
Participants/Inclusion and exclusion criteria
Patients aged 18–50 years who are candidates for early implant placement (Early Implants)Inclusion Criteria: Patients aged 18–50 years, candidates for early implant placement , with four-wall intact dental sockets, and in good general health without uncontrolled systemic diseases such as diabetes and etc.Exclusion Criteria: Patients with a history of allergy to melatonin or xenograft, chronic smokers (>10 cigarettes/day) or alcohol and pregnant or lactating women were excluded to prevent adverse effects and avoid confounding factors affecting bone regeneration.
Intervention groups
In the intervention group, following tooth extraction, the extraction socket is filled with xenograft bone powder combined with melatonin.
Main outcome variables
Effect of topical melatonin combined with xenograft on alveolar bone regeneration and attached gingiva thickness following tooth extraction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251201068171N1
Registration date:2026-01-30, 1404/11/10
Registration timing:registered_while_recruiting
Last update:2026-01-30, 1404/11/10
Update count:0
Registration date
2026-01-30, 1404/11/10
Registrant information
Name
Mahdi Nozhati Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3784 2502
Email address
mahdinozhati2002@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-20, 1404/10/30
Expected recruitment end date
2026-03-11, 1404/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using melatonin hormone locally along with xenograft on bone regeneration and improving the quality of soft tissue in the extracted tooth area
Public title
The effect of topical melatonin combined with xenogeneic bone graft powder on bone formation and the width of keratinized gingiva in the extraction site.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-restorable teeth who are candidates for implant treatment
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Bone specimens derived from xenograft alone and from xenograft with melatonin
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method:
In this split-mouth study, each patient served as their own control. Sites within the mouth (e.g., right or left side) were randomly assigned to the intervention or control. Random allocation was performed using a random number table to minimize bias.
Blinding (investigator's opinion)
Double blinded
Blinding description
1 Patient Blinding
• Patients were unaware of which side of the mouth was assigned to the intervention group (melatonin + xenograft) and which side was assigned to the control group (xenograft only)
2 Surgeon and Evaluator Blinding
• The surgeon was unaware of the allocation during the intervention and tissue sampling
• Clinical and histological evaluators were also blinded to the allocation of each site
3 Allocation Control
• Group allocation was performed by an independent person and the information was kept in sealed envelopes
• The envelopes were opened only at the time of the intervention by the responsible operator
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golestan Boys' Dormitory, Sari Zamin, First Uphill of Mirdamad, University Square, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5165995131
Approval date
2025-11-22, 1404/09/01
Ethics committee reference number
IR.TBZMED.REC.1404.622
Health conditions studied
1
Description of health condition studied
Dental socket preservation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Primary Outcome Variable Description:The primary outcome variable is the amount of newly formed bone in the dental socket after using melatonin combined with xenograft compared to xenograft alone.
Timepoint
Time Points of Measurement: 1. Baseline (before tooth extraction / intervention): Measurement of attached gingiva thickness as a reference for soft tissue evaluation 2. Immediately after material placement in the dental socket: Initial clinical observations recorded 3. Week 1 and Week 2 post-surgery: Clinical follow-up including suture closure, swelling, infection, and unpleasant odor 4. Two months post-surgery: • Bone sampling from both intervention and control sites before implant placement • Radiographic assessment to evaluate bone status and structural changes
Method of measurement
The bone formation is measured using histological analysis (histomorphometry) or image analysis software (Image-Pro Plus) • Results are reported as the percentage of new bone relative to the total tissue section area
2
Description
The secondary outcome variable is attached gingiva thickness around the dental socket, reflecting soft tissue changes after using melatonin combined with xenograft compared to xenograft alone.
Timepoint
1. Baseline (before tooth extraction / intervention): Measurement of attached gingiva thickness using a periodontal probe 2. Immediately after material placement in the dental socket: Recording initial clinical observations of the gingiva 3. Week 1 and Week 2 post-surgery: Clinical assessment of the gingiva, including swelling, inflammation, and soft tissue healing 4. Two months post-surgery: Re-measurement of attached gingiva thickness to evaluate soft tissue changes
Method of measurement
Measurements are performed using a periodontal probe and recorded at predefined time points.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, following tooth extraction, the extraction socket is filled with xenograft bone powder combined with melatonin.This study is designed as a split-mouth trial, in which one side of each patient’s mouth is randomly assigned to receive the intervention (xenograft with melatonin), while the contralateral side serves as the control group and receives xenograft bone powder alone without melatonin.
Category
Treatment - Drugs
2
Description
Control group: In the control group, following tooth extraction, the extraction socket is filled with xenograft bone powder without melatonin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Mahdi Nozhati Maleki
Street address
Oral and Maxillofacial Surgery Department٬Ground Floor, Entrance 1, Tabriz Faculty of Dentistry, next to Imam Reza Hospital, end of Golgasht Street, Daneshgah Street, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166674713
Phone
+98 41 3335 5965
Email
Mahdinozhati2002@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
معاون تحقیقات و فناوری
Street address
Golestan Boys’ Dormitory, Sari Zamin, First uphill of Mirdamad, Akhar-e Maralan, University District, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5165995131
Phone
+98 41 3784 2502
Email
mahdinozhati2002@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahdi Nozhati Maleki
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Golestan Boys' Dormitory, Sari Zamin, First Uphill of Mirdamad, University Square, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5165995131
Phone
+98 41 3784 2502
Fax
Email
Mahdinozhati2002@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzain Ahmadpour pournak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golestan Boys' Dormitory, Sari Zamin, First Uphill of Mirdamad, University Square, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5165995131
Phone
+98 41 3784 2502
Fax
Email
phoenixinfire@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzain Ahmadpour pournak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golestan Boys' Dormitory, Sari Zamin, First Uphill of Mirdamad, University Square, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5165995131
Phone
+98 41 3784 2502
Fax
Email
phoenixinfire@ymail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data will be published as part of a peer-reviewed article
When the data will become available and for how long
Access to the data will be available after final publication of the article.
To whom data/document is available
The data may be accessible by the general public
Under which criteria data/document could be used
provided that proper citation to the published article is made.
From where data/document is obtainable
Requests for access to the data should be directed to the corresponding author via email.
What processes are involved for a request to access data/document
Correspondence via email with the corresponding author.