| CTRI Number |
CTRI/2024/11/077001 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Nine months comparison peri-implant scores of dental implants placed with low-speed drilling without irrigation and conventional drilling with irrigation |
|
Scientific Title of Study
|
Clinico-radiographic comparison of dental implants placed with low-speed drilling without irrigation and conventional drilling with irrigation – A randomized controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1315-2816 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aaron F Gomes |
| Designation |
Professor and Head, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140
Dehradun UTTARANCHAL 248140 India |
| Phone |
9860597402 |
| Fax |
|
| Email |
aarongomes@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aaron F Gomes |
| Designation |
Professor and Head, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140
UTTARANCHAL 248140 India |
| Phone |
9860597402 |
| Fax |
|
| Email |
aarongomes@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aaron F Gomes |
| Designation |
Professor and Head, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140
UTTARANCHAL 248140 India |
| Phone |
9860597402 |
| Fax |
|
| Email |
aarongomes@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aaron F Gomes |
| Address |
Dept of Periodontology and Oral Implantology, Uttaranchal Dental and Medical Research Institute, Majri Grant, Dehradun 248140 |
| 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 |
| Aaron F Gomes |
Uttaranchal Dental and Medical Research Institute |
Room No 10, Dental Implant Centre, Dept of Periodontology and Oral Implantology, Uttaranchal Dental and Medical Research Institute, Majri Grant, Haridwar road Dehradun UTTARANCHAL |
9860597402
aarongomes@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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, (2) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
A cohort of partially edentulous patients will be treated with placement of dental implants with a drilling speed of 800-400 rpm with copious saline irrigation. These particpants will be evaluated for periimplant crestal bone levels and periimplant plaque and mucosal scores at 3, 6, and 9 months after implant fixture surgery |
| Intervention |
Test Group |
A cohort of partially edentulous patients will be treated with placement of dental implants with an intermittent drilling at a speed of 200-100 rpm with no saline irrigation. These particpants will be evaluated for periimplant crestal bone levels and periimplant plaque and mucosal scores at 3, 6, and 9 months after implant fixture surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Indian patient
Partially edentulous
Sufficient bone height/width for implant placement
Ready to come for 6-month recall |
|
| ExclusionCriteria |
| Details |
Active Periodontal Infection.
Unresolved extraction wounds or inadequate bone at the time of implant placement
Lack of motivation and/or compliance
Moderate/heavy smoking
Bruxism
Any medical condition that contraindicates surgery
Pregnancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peri implant crestal bone level at mesial and distal aspect of the implant |
R0- radiograph taken soon after placement of implant.
R3- Radiograph taken 3 months after placement of implant and before placing the final prosthesis.
R6- Radiograph taken 6 months after placement of implant, 3 months after placement of final prosthesis.
R9- radiograph taken after 9 months of implant placement surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Peri implant mucosal index
modified Plaque index
modified Sulcus Bleeding Index
Implant mobility scale
Peri-implant Sulcus Probing Depth
|
6 and 9 months after implant placement surgery |
|
|
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)
|
22/11/2024 |
| 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) |
Closed to Recruitment of Participants |
|
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 [aarongomes@hotmail.com].
- For how long will this data be available start date provided 01-11-2025 and end date provided 30-11-2030?
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
|
Background: The present study aims to investigate the changes in crestal bone levels and the changes in implant scores after placing implants using two different drilling-protocols, i.e., low-speed-drilling without irrigation and conventional-drilling with saline irrigation, over a follow-up of 9 months. Nh Null hypothesis: there is no difference in the mesial distal crestal bone levels, peri implant mucosal index value, modified plaque index score, modified sulcus bleeding index scores, implant mobility scale, peri implant sulcus probing depth between implants placed after drilling with 800-400 rpm with copious saline irrigation and implants placed after intermittently drilling with 200-100 rpm without irrigation. Material and Methods: Twenty participants will be enrolled from a dental teaching institute. Participants who fulfill the inclusion criteria will be randomly divided equally in two study groups: 1) test group: low-speed-drilling at 200-100 rpm without irrigation and 2) control group: conventional-drilling at 800-400rpm with saline irrigation. The changes in proximal radiographic crestal bone levels will be measured at baseline (immediately after placement of implant), and after 3-, 6-, 9- months. Changes in crestal bone levels will be compared at time-intervals of 3-, 6- and 9- months. These changes will also be calculated as a percentage of implant length. Clinical and radiographic scores of modified Plaque Index, Peri-implant Mucosal Index, modified Sulcus Bleeding Index, Misch’s Clinical Implant Mobility Scale, Peri-implant sulcus probing depth, Peri-implant clinical attachment level, Presence of peri-implant suppuration, Presence of peri-implant radiolucencies will be evaluated after 6-, 9 months in both groups. Second stage surgery will be performed after 3-4 months and cement retained implant crowns will be delivered. Data analysis will be performed using paired t-test between both groups and a p-value of ≤0.05 was considered statistically significant. |