| CTRI Number |
CTRI/2025/06/088681 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
05/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on the Effect of Melatonin in Helping Bone Growth After dental implant Placement in Adults |
|
Scientific Title of Study
|
Effect of melatonin on bone formation when placed in the jumping gap in immediate dental implant placement - a case control study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anisha Grover |
| Designation |
Post graduate student |
| Affiliation |
I.T.S. Dental college, hospital and research centre, greater noida |
| Address |
Department of oral and maxillofacial surgery, I.T.S. Dental College, hospital and research Centre, knowledge park 3, greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9899942878 |
| Fax |
|
| Email |
dranisha.grover07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himanshu Bhutani |
| Designation |
Professor |
| Affiliation |
I.T.S. Dental college, hospital and research centre, greater noida |
| Address |
Department of oral and maxillofacial surgery, I.T.S. Dental College, hospital and research Centre, knowledge park 3, greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9971772321 |
| Fax |
|
| Email |
dr.himanshu@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshu Bhutani |
| Designation |
Professor |
| Affiliation |
I.T.S. Dental college, hospital and research centre, greater noida |
| Address |
Department of oral and maxillofacial surgery, I.T.S. Dental College, hospital and research Centre, knowledge park 3, greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9971772321 |
| Fax |
|
| Email |
dr.himanshu@its.edu.in |
|
|
Source of Monetary or Material Support
|
| Room No. 5, 1st floor, Department of Oral and Maxillofacial Surgery, I.T.S. Dental College, hospital and research center, knowledge park 3, Greater Noida, Uttar Pradesh, India-201310 |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Greater Noida |
| Address |
Room No. 5, 1st floor, Department of Oral and Maxillofacial Surgery, I.T.S. Dental College, hospital and research center, knowledge park 3, Greater Noida, Uttar Pradesh, India-201310 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anisha Grover |
I.T.S. Dental college, Greater Noida |
Department of Oral and maxillofacial Surgery, I.T.S. Dental College, hospital and research Centre
knowledge park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9899942878
dranisha.grover07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S. Dental college, hospital and research Centre Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Immediate dental placement followed by customized gingival former |
Immediate dental implant placement in 15 patients followed by a customized gingival former. Bone density and marginal bone level will be evaluated radiographically along with gingival response and papilla height will be assessed clinically |
| Intervention |
Melatonin Placement in Jumping gap in immediate dental implant placement |
Melatonin will be placed in paste form in the jumping gap which occurs after immediate dental implant placement in 15 patients followed by a customized gingival former. Bone density and marginal bone level will be evaluated radiographically along with gingival response and papilla height will be assessed clinically. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient having a hopeless tooth indicated for extraction (due to an unrestorable fracture or a carious lesion) requiring immediate dental implant placement.
The absence of any active infection/pus discharge and bone dehiscence on buccal wall of tooth socket.
Intact socket walls.
ASA Grade I and II.
Expected jumping gap of ≤ 2mm during implant simulation.
|
|
| ExclusionCriteria |
| Details |
Aggressive periodontitis.
ASA Grade III and above.
External root resorption.
Smoking.
Patients who are at high risk of hormonal disturbances, mental disorders, seizures.
Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)CLINICAL ASSESSMENT by pink esthetic score to check gingival response and to assess the papilla height.
2)RADIOGRAPHIC ASSESSMENT by IOPA and CBCT to evaluate bone density and marginal bone level |
At baseline- radiographic assessment by IOPAR and CBCT
At 3 months - radiographic assessment by IOPAR and CBCT and clinical assessment by pink esthetic score
At 6 months- radiographic assessment by IOPAR and CBCT and clinical assessment by pink esthetic score
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study the clinical and radiological changes occurring after placement of melatonin in jumping gap in immediately placed dental implants.
2)To study the clinical and radiological changes occurring when the jumping gap left unfilled in immediately placed dental implants.
3)To compare the bone formation in the jumping gap when it is filled with melatonin v/s when the gap is left unfilled in immediately placed dental implants.
|
At 0,3 and 6 months postoperatively |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to assess the effect of melatonin on bone formation when placed in the jumping gap which is present after immediate dental implant placement. All the patients visiting the Department of oral and maxillofacial surgery of I.T.S. Dental College, Greater Noida and fulfilling the inclusion and exclusion criteria will be selected for the study to complete a sample size of 30 patients who will be randomly divided into two groups. This study will include patients between 25 and 65 years of age, having a hopeless tooth indicated for extraction (due to an unrestorable fracture or a carious lesion) requiring immediate dental implant placement. In 15 patient melatonin paste will be placed in the jumping gap after immediate dental implant placement followed by a customized gingival former to compare with the other 15 patients in the control group in which immediate dental implant placement will be done followed by customized gingival former. This study will assess the clinical and radiological outcomes of immediate dental implant placement with the use of a melatonin filled in the jumping gap to promote bone formation by evaluating the marginal bone level and bone density through IOPA at 0,3 and 6 months postoperatively and CBCT at 3 and 6 months postoperatively. Clinical assessment of the gingival response and the papilla height will be done with the pink esthetic score at 0,3 and 6 months postoperatively. All the patients will be prescribed with standard antibiotic and anti-inflammatory protocol along with necessary instructions after the treatment. |