| CTRI Number |
CTRI/2025/03/083144 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate and compare the effects of one step and two step dental implant surgery on soft and hard tissues surrounding the dental implant |
|
Scientific Title of Study
|
Comparative evaluation of effect of two-stage and one-stage implant surgery on peri-implant soft and hard tissues: A Randomized control trial |
| 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 Shreya Bhole |
| Designation |
Post graduate student |
| Affiliation |
Jawahar Medical Foundation,Annasaheb Chudaman Patil memorial Dental College , Dhule |
| Address |
Department of periodontology, Room No3, Annasaheb Chudaman Patil memorial Dental college,Sakri road,Dhule,tal.Dist-Dhule,Affiliated to MUHS Nashik.
Dhule
MAHARASHTRA
424001
India |
| Phone |
9423811062 |
| Fax |
|
| Email |
shreyavbhole@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruhee Chawla |
| Designation |
Professor |
| Affiliation |
Jawahar Medical Foundation,Annasaheb Chudaman Patil memorial Dental College , Dhule |
| Address |
Department of periodontology, Room No3, Annasaheb Chudaman Patil memorial Dental college,Sakri road,Dhule,tal.Dist-Dhule,Affiliated to MUHS Nashik.
Dhule
MAHARASHTRA
424001
India |
| Phone |
7028373727 |
| Fax |
|
| Email |
dr.ruhichawla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruhee Chawla |
| Designation |
Professor |
| Affiliation |
Jawahar Medical Foundation,Annasaheb Chudaman Patil memorial Dental College , Dhule |
| Address |
Department of periodontology, Room No3, Annasaheb Chudaman Patil memorial Dental college,Sakri road,Dhule,tal.Dist-Dhule,Affiliated to MUHS Nashik.
Dhule
MAHARASHTRA
424001
India |
| Phone |
7028373727 |
| Fax |
|
| Email |
dr.ruhichawla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, Room no 3, Annasaheb Chudaman Patil Memorial Dental College,Sakri road, Dhule pin 424001,country-Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Shreya Bhole |
| Address |
Department of Periodontology, Room no 3, Annasaheb Chudaman Patil Memorial Dental College,Sakri road, Dhule pin 424001,country-Maharashtra |
| 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 Shreya Bhole |
Annasaheb Chudaman Patil Memorial Dental College |
Department of periodontology, Room No3, Annasaheb Chudaman Patil memorial Dental college,Sakri road,Dhule,tal.Dist-Dhule,Affiliated to MUHS Nashik.
Dhule
MAHARASHTRA |
9423811062
shreyavbhole@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JMFs ACPM Dental College Dhule Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
One-stage dental implant surgery |
1. First visit-CBCT will be obtained preoperatively.The surgical procedure will be carried out in complete sterile condition. The delayed implant placement will be done. 0.2% Chlorhexidine mouthwash as the preoperational prophylactic protocol will be used prior surgery. Surgical procedure will be started by giving 2% lidocaine and epinephrine 1/100000 followed by elevating mucoperiosteal flap by giving mid crestal incision. The implants selected for the present study will be in the range of 4-5 mm in diameter and 8.5-10 mm in length.Then, the fixtures will be placed and healing abutment will be placed.Second visit-After 3 weeks the impression will be recorded and parameters will be recorded such as Modified Plaque index
Modified gingival index
Simplified gingival index
3.Third visit- The prosthesis will be delivered. 4.Fourth visit-The parameters will be recorded that are mentioned above after 3 months.5.Fifth visit- The parameters will be recorded that are mentioned above and CBCT will be recorded and marginal bone loss will be seen pre-operatively and post-operatively on CBCT. |
| Comparator Agent |
Two stage dental implant surgery |
1.First visit- CBCT will be obtained preoperatively. The surgical procedure will be carried out in complete sterile condition. The delayed implant placement will be done. 0.2% Chlorhexidine mouthwash as the preoperational prophylactic protocol will be used prior surgery. Surgical procedure will be started by giving 2% lidocaine and epinephrine 1/100000 followed by elevating mucoperiosteal flap by giving mid crestal incision. The implants selected for the present study will be in the range of 4-5 mm in diameter and 8.5-10 mm in length.Then, the fixtures will be placed and cover screw will be placed.2.Second visit-The healing abutment will be placed after 3 months.3.Third visit-After 3 weeks the impression will be recorded and parameters will be recorded such as Modified Plaque index Modified gingival index Simplified gingival index 3.Fourth visit- The prosthesis will be delivered. 4.Fifth visit-The parameters will be recorded that are mentioned above after 3 months.5.Sixth visit- The parameters will be recorded that are mentioned above and CBCT will be recorded and marginal bone loss will be seen pre-operatively and post-operatively on CBCT. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy patients
2. Absence of oral and dental disorders
3. At least one tooth missing posterior to maxillary or mandibular canine with extraction period of 4 to 6 months.
4. Age ranging from 18 – 65 years.
5. Healed osseous architecture sufficient to receive an implant
6. Smoking fewer than 10 cigarettes/day. i.e (light smoker)
7. Patients who are not indicated for soft tissue or hard tissue augmentation procedure
|
|
| ExclusionCriteria |
| Details |
1. Patients having Systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, hepatic diseases, bone metabolic diseases, cardiovascular diseases, lung diseases, malignancies or disorders that compromise wound healing, radiation, or immunosuppressive therapy)
2. Contra indication for implant surgery
3. Moderate or heavy smokers and chronic alcoholic patients.
4. Patients who have psychological disorders
5. No history of periodontal therapy within the previous months.
6. Local problem such as gingival or periodontal disease.
7. Patients who have less than 2 mm of keratinized mucosa width.
8. Patients who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To bypass the second stage dental implant surgery in order to reduce the treatment period and to provide the patient with early function. |
Modified Plaque index
Modified gingival index
Simplified gingival index -baseline, 3 months and 6 months and Marginal bone loss- at baseline and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of one stage dental implant surgery on peri implant soft and hard tissues in terms of bleeding of probing, peri-implant mucosal conditions and marginal bone loss. |
Modified Plaque index
Modified gingival index
Simplified gingival index -baseline, 3 months and 6 months and Marginal bone loss- at baseline and 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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/04/2025 |
| 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="4"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shreyavbhole@gmail.com].
- For how long will this data be available start date provided 20-03-2025 and end date provided 16-10-2026?
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
|
This is single blind randomized clinical trial. The primary objective is To bypass the second stage dental implant surgery in order to reduce the treatment period and to provide the patient with early function and secondary objective is to evaluate the effect of one stage dental implant surgery on peri-implant soft and hard tissues in terms of bleeding of probing, peri-implant mucosal conditions and marginal bone loss. The following parameters will be recorded such as modified gingival index, simplified gingival index, modified plaque index at baseline, 3 months and 6 months and marginal bone loss will be recorded at baseline and 6 months at CBCT. |