| CTRI Number |
CTRI/2024/11/077050 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Nine months comparison of hard and soft tissues around implants that were placed surgically using irrigation solution at two different temperatures |
|
Scientific Title of Study
|
Clinico-radiographic comparison of peri implant tissue after implant site osteotomy using irrigation solution at two different temperatures: A randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1315-3090 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rukhshana Khatoon |
| Designation |
PG Student, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room No 10, Dept of Periodontology and Oral Implantology,
Uttaranchal Dental and Medical Research Institute, Mazri Grant,
near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India.
Dehradun
UTTARANCHAL
248140
India |
| Phone |
8979361800 |
| Fax |
|
| Email |
Khatoonruk213@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Aaron F Gomes |
| Designation |
PG Guide, Professor and Head, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Uttaranchal Dental and Medical Research Institute, Mazri Grant,
near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India.
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9860597402 |
| Fax |
|
| Email |
aarongomes@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rukhshana Khatoon |
| Designation |
PG Student, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room No 10, Dept of Periodontology and Oral Implantology,
Uttaranchal Dental and Medical Research Institute, Mazri Grant,
near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India.
Dehradun
UTTARANCHAL
248140
India |
| Phone |
8979361800 |
| Fax |
|
| Email |
Khatoonruk213@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rukhshana Khatoon |
| Address |
Dept of Periodontology, Uttaranchal Dental and Medical Research Institute, Majri Granr, Dehradun |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Rukhshana Khatoon |
Uttaranchal Dental and Medical Research Institute |
Room No 10, Dept of Periodontology and Oral Implantology, Uttaranchal Dental and Medica Research Institute, Majri Grant, Haridwar road,
Dehradun
UTTARANCHAL |
8979361800
khatoonruk213@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC UDMRI |
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 |
| Intervention |
Surgical dental implant placement with the help of irrigation solution at temperature between 4°C and 8°C. |
Dental implants are prosthetically driven surgical modality which we usually place under controlled environment that includes temperature control of irrigation solution between 26°C and 30°C, but during this intervention we will use irrigation solution at temperature between 4°C and 8°C. |
| Comparator Agent |
Surgical dental implant placement with the help of irrigation solution at temperature between 26°C and 30°C. |
Dental implants are prosthetically driven surgical modality which we shall place under controlled environment that includes temperature control of irrigation solution between 26°C and 30°C. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) healthy Indian patient
2) partially edentulous
3) enough bone height/width for implant placement
4) ready to come for 6-month recall |
|
| ExclusionCriteria |
| Details |
1) Active Periodontal Infection (no periodontal pocket depth greater than 3 mm at the time of implant placement).
2) unresolved extraction wounds or inadequate bone at the time of implant placement
3) lack of motivation and/or compliance
4) moderate/heavy smoking
5) uncontrolled diabetes mellitus
6) bruxism
7) a medical condition that contraindicates surgery
8) pregnancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Level of alveolar bone crest of control and intervention group. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Level of alveolar bone crest of control group. |
Baseline |
| Level of alveolar bone crest of control group |
3 months |
| Level of alveolar bone crest of intervention group. |
Baseline |
| Level of alveolar bone crest of intervention group |
3 months |
| Clinical changes around implant placed. |
3 months. |
| Clinical changes around implant placed |
6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [khatoonruk213@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The trial will primarily perform in the department of periodontology and oral implantology UDMRI Dehradun in which we will perform prosthetically driven surgical modality that is dental implant surgery. Traditionally this procedure is performed using irrigation solution which is at room temperature (26°C to 30°C). In this study we are considering to change the temperature of irrigation solution to colder conditions (4°C to 8°C). We will observe crestal bone level before placement of dental implant and after 6 months of implant placement in both groups. Additionally, we will observe the crestal bone levels at 3 months after implant placement. We will also observe clinical change around the implants during this trial and will report the observations. |