| CTRI Number |
CTRI/2025/05/087194 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Dental Implant Techniques Using Traditional Drilling and Piezosurgery in Adults: Effects on Plaque, Bleeding, Healing, and Bone Loss |
|
Scientific Title of Study
|
Evaluation of clinical parameters following dental implant placement by conventional drilling and piezosurgery |
| 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 Mahvish Iftkhar |
| Designation |
Post-graduate Student |
| Affiliation |
Himachal Institute of Dental Sciences, Paonta sahib , HP |
| Address |
Himachal Institute of Dental Sciences, Department of Periodontics and Implantology, room no 4, Paonta sahib , Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173025
India |
| Phone |
8077405061 |
| Fax |
|
| Email |
mahvishiftkhar91298@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Kumar |
| Designation |
Professor |
| Affiliation |
Himachal Institute of Dental Sciences, Paonta sahib , HP |
| Address |
Himachal Institute of Dental Sciences, Department of Periodontics and Implantology, room no 4, Paonta sahib , Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173025
India |
| Phone |
9996054139 |
| Fax |
|
| Email |
drmks78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Kumar |
| Designation |
Professor |
| Affiliation |
Himachal Institute of Dental Sciences, Paonta sahib , HP |
| Address |
Himachal Institute of Dental Sciences, Department of Periodontics and Implantology, room no 4, Paonta sahib , Himachal Pradesh
HIMACHAL PRADESH
173025
India |
| Phone |
9996054139 |
| Fax |
|
| Email |
drmks78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Himachal Institute of Dental Sciences, Department of Periodontics and Implantology, room no 4, Paonta sahib , Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Mahvish Iftkhar |
| Address |
Himachal Institute of Dental Sciences, Department of Periodontics and Implantology, room no 4, Paonta sahib , Himachal Pradesh |
| 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 |
| Dr Mahvish Iftkhar |
Himachal Institute of Dental Sciences, Paonta sahib |
Himachal Institute of Dental Sciences, Department of Periodontics and Implantology, room no 4, Paonta sahib , Himachal Pradesh
Sirmaur
HIMACHAL PRADESH |
8077405061
mahvishiftkhar91298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HIDS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional drilling technique for dental implant osteotomy |
The comparator involves the use of standard rotary instruments (high-speed drills and burs) to prepare the osteotomy site for dental implant placement. The procedure is carried out under local anesthesia in a single session, using sequential drills according to the implant system’s protocol. The standard protocol includes pilot drilling followed by progressive enlargement of the osteotomy using stainless steel or titanium burs. |
| Intervention |
Piezosurgery technique for dental implant osteotomy |
Piezosurgery is a minimally invasive surgical technique that uses ultrasonic microvibrations to perform bone cutting. In this study, a piezoelectric surgical unit will be used to prepare the osteotomy site for dental implant placement. The technique allows precise cutting with minimal trauma to surrounding soft tissues and improved patient comfort.
The procedure will be carried out in a single session under local anesthesia in the mandibular or maxillary region as per implant site requirement.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who are willing to comply with all the study related procedures after signing an informed consent form.
2.Both males and female patients will be taken.
3.Non-contributing medical history.
4.Good oral Hygiene.
5.Edentulous area requiring implant placement.
6.AGE greater than 20 years
|
|
| ExclusionCriteria |
| Details |
1.Osteogenesis related disorders
2.Taking medication that affect bone formation
3.Oral/Parental Rheumatic Drugs
4.Uncontrolled hypertension
5.Diabetes mellitus
6.Oral Mucosal Lesions
7.History of radiation therapy
8.Alcoholism
9.Smokers
10.Severe bruxism or clenching
11.Poor oral hygiene
12.Being pregnant/lactating
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare marginal bone level clinically and radiographically after implant placement with conventional drilling and piezosurgery. |
3 months, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare clinical parameters such as implant probing depth, healing index, plaque index, gingival index, bleeding index in both groups. |
3 months, 6 months, 12 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)
|
30/05/2025 |
| 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) |
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 - NO
|
|
Brief Summary
|
This
randomized controlled clinical trial aims to compare the clinical outcomes of
dental implant placement using two different osteotomy techniques: conventional
drilling and piezosurgery. The study involves 20 healthy volunteers requiring
implant placement, with 10 patients in each group. Key clinical parameters such
as implant probing depth, healing index, plaque index, gingival index, bleeding
index will be assessed at defined intervals to evaluate the efficacy and
patient comfort associated with each technique. The goal is to determine
whether piezosurgery offers clinical advantages over traditional drilling
methods in implant dentistry. |