| CTRI Number |
CTRI/2024/07/071437 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the changes brought to periodontium and bone by bone level and tissue level implants: A Randomized Control Trial |
|
Scientific Title of Study
|
Evaluation of peri implant soft tissue and hard tissue in bone level and tissue level implants: 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 |
Amit Kashyap M R |
| Designation |
Junior Resident |
| Affiliation |
Rajarajeshwari Dental college and hospital |
| Address |
Room Number 3, Department of Oral and maxillofacial surgery
Room Number 3, Department of Oral and maxillofacial surgery
Bangalore
KARNATAKA
560074
India |
| Phone |
9448914880 |
| Fax |
|
| Email |
amitkashyapmr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shruthi R |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari Dental college and hospital |
| Address |
Room Number 3, Department of Oral and maxillofacial surgery
Room Number 3, Department of Oral and maxillofacial surgery
Bangalore
KARNATAKA
560074
India |
| Phone |
9880340206 |
| Fax |
|
| Email |
drshruthir@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Amit Kashyap M R |
| Designation |
Junior Resident |
| Affiliation |
Rajarajeshwari Dental college and hospital |
| Address |
Room Number 3, Department of Oral and maxillofacial surgery
Room Number 3, Department of Oral and maxillofacial surgery
Bangalore
KARNATAKA
560074
India |
| Phone |
9448914880 |
| Fax |
|
| Email |
amitkashyapmr@gmil.com |
|
|
Source of Monetary or Material Support
|
| Patient Shall Pay for the procedures being done. |
|
|
Primary Sponsor
|
| Name |
RajaRajeswari Dental College & Hospital |
| Address |
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074 |
| 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 |
| Amit Kashyap M R |
Rajarajeswari Dental College And Hospital |
Room Number 3, Department of Oral and Maxillofacial Surgery
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore Rural
KARNATAKA |
9448914880
amitkashyapmr@gmil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Rajarajeswari Dental And Hospital |
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 |
Placement of Bone level implants |
It is used to compare the Marginal bone loss, implant stability, Modified Sulcus Bleeding Index, Peri-Implant Probing Depth, Keratinized tissue height and Gingival Biotype |
| Intervention |
Placement of tissue level and bone level implants with prosthetic rehabilitation. |
The placed implants shall be prosthetically rehabilitated 3 months post placement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group of 18 to 60 years
2. Patient Should be partially edentulous in posterior region of maxilla or mandible
3. Patients with good oral hygiene
4. ASA I and ASA II
|
|
| ExclusionCriteria |
| Details |
ASA III and ASA IV, Pregnant or nursing women, Patients smoking more than 10 cigarettes a day, poor periodontal status, need for regenerative procedure and Intake of drugs that can interfere with bone healing and remodeling
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Implant Stability(ISQ), Modified Sulcus Bleeding Index (Score 0-3), Peri-Implant Probing Depth, Marginal Bone Loss (mesial side and distal side), Keratinized tissue height and Gingival Biotype(Thin or Thick) |
Implant Stability at 0, 3 and 6 months:
Modified Sulcus Bleeding Index 0, 3 and 6 months:
Peri-Implant Probing Depth 0, 3 and 6 months:
Marginal Bone Loss 0, 3 and 6 months:
Keratinized tissue height 3 and 6 months and Gingival Biotype |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mplant Stability(ISQ), Modified Sulcus Bleeding Index (Score 0-3), Peri-Implant Probing Depth, Marginal Bone Loss (mesial side and distal side), Keratinized tissue height and Gingival Biotype(Thin or Thick) |
Implant Stability at 0, 3 and 6 months:
Modified Sulcus Bleeding Index 0, 3 and 6 months:
Peri-Implant Probing Depth 0, 3 and 6 months:
Marginal Bone Loss 0, 3 and 6 months:
Keratinized tissue height 3 and 6 months and Gingival Biotype |
|
|
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 2 |
|
Date of First Enrollment (India)
|
10/08/2024 |
| 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="2"
Months="5"
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 - NO
|
|
Brief Summary
|
Background: Osseo-integration is a prerequisite for long-term implant stability. Proper soft tissue seal to the titanium surfaces at the most coronal aspect of the implant body is required to prevent pathology that may interfere with osseo-integration process. Conventional or bone level implants involve a two-stage surgery. Here, first the implant is placed at bone level after flap elevation and sutured for osseo-integration. In second stage, after 10-14 weeks, again a flap is raised to place the gingival former for another 3 weeks. Here the implant-abutment junction is in close proximity to the crestal bone. It has been observed that the implant-abutment junction creates a micro-gap that creates path for the inflammatory infiltrate to cause marginal bone loss (die-back effect) and apical migration of junctional epithelium. Better understanding of peri implant bone regeneration has led to more refined concepts of implant loading. Tissue-level implants involve a single stage surgery where the tissue level abutment is placed along with the implant. It is attributed to creating a good mucosal seal of adequate width that mimics the biologic width. They have been attributed to eliminate the implant-abutment junction at the crestal bone level and shifts this junction at the tissue level, thus eliminating the micro-gap between these components. Prosthetic procedures don’t disturb the mucosal seal and protects it from contaminated oral surface. In tissue level implants healing of bone and gingiva occurs simultaneously. It has been observed that this creates an early mucosal seal and disturb its seal during prosthetic steps. The purpose of this study is to evaluate peri-implant soft-tissue and hard-tissue health conditions and changes seen in bone level and tissue level implants post prosthetic rehabilitation in these implants
1. To assess the peri-implant soft tissue thickness in bone level and tissue level implants both pre-operatively and post-operatively. 2. To assess the peri-implant soft changes seen in bone level and tissue level implants. 3. To assess any crestal bone changes around the implant in bone level and tissue level implants. 4. To evaluate the peri-implant soft-tissue and hard-tissue changes following prosthetic rehabilitation in bone level and tissue level implants.
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