| CTRI Number |
CTRI/2024/12/078669 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bone loss around the implant placed in thin and thick gingiva |
|
Scientific Title of Study
|
Comparative evaluation of crestal bone loss levels around dental implants placed in thick and thin mucosal tissues
- a clinicoradiographic study.
|
| 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 Bhutada Chetan Gopal |
| Designation |
Post graduate student |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Dept. Of Periodontology And Implantology, Room no. 4, K.K. Campus, Magulla village, Virajpet, Kodagu, Karnataka, 571218
Kodagu KARNATAKA 571218 India |
| Phone |
9284316954 |
| Fax |
|
| Email |
chetanbhutada6059@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bhutada Chetan Gopal |
| Designation |
Post graduate student |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Dept. Of Periodontology And Implantology, Room no. 4, K.K. Campus, Magulla village, Virajpet, Kodagu, Karnataka, 571218
Kodagu KARNATAKA 571218 India |
| Phone |
9284316954 |
| Fax |
|
| Email |
chetanbhutada6059@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Krishnaraj G N |
| Designation |
Professor |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Dept. Of Periodontology And Implantology, Room no. 4, K.K. Campus, Magulla village, Virajpet, Kodagu, Karnataka, 571218
Kodagu KARNATAKA 571218 India |
| Phone |
7259456314 |
| Fax |
|
| Email |
dentalsolutions@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg Institute Of Dental Sciences, Dept Of Periodontics And Implantology, Room no. 4 K.K. Campus, Magulla village, Virajpet, Kodagu, Karnataka, 571218 |
|
|
Primary Sponsor
|
| Name |
Dr. Bhutada Chetan Gopal |
| Address |
Coorg Institute Of Dental Sciences, Dept Of Periodontics And Implantology, Room no. 4 K.K. Campus, Magulla village, Virajpet, Kodagu, Karnataka, 571218 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| indian society of periodontology |
721, Phase 3B-1, Mohali
SAS Nagar. 160060
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhutada Chetan Gopal |
Coorg Institute Of Dental Sciences |
Dept Of Periodontics And Implantology, Room no. 4 K.K. Campus, Magulla village, Virajpet, Kodagu, Karnataka, 571218 Kodagu KARNATAKA |
9284316954
chetanbhutafa6059@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Coorg Institution Of Dental Science |
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 |
dental titanium implant |
Measuring the crestal bone loss levels around the subcrestal implants placed in edentulous region covering thick gingival tissue. immediately after implant placement,after 6 months of placement and after 1 year of placement. |
| Comparator Agent |
dental titanium implant |
Measuring the crestal bone loss levels around the subcrestal implants placed in edentulous region covering thin gingival tissue. immediately after implant placement,after 6 months of placement and after 1 year of placement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Eighteen years of age to sixty five years of age.
2. Fully healed bone sites. (at least 6 months after tooth extraction)
3. No bone augmentation procedures before and during implant placement.
4. Edentulous gap for at least 1 implant in any region of the mouth with minimum 1mm distance range from adjacent tooth/teeth.
5. No medical contraindication for implant surgery.
6. Edentulous site of implant in any region of the mouth with minimum 1mm of mucosal tissue thickness.
|
|
| ExclusionCriteria |
| Details |
1. Poor oral hygiene.
2. Symptoms or history of periodontitis or peri-implantitis treatment.
4. Smoker and alcoholic person.
5. Patients with systemic diseases.
6. Alveolar ridges with bone defects at implantation sites.
7. Attached gingiva ≤ 2 mm.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| More crestal bone loss around the implants placed in thin mucosal tissue. |
crestal bone loss will be checked around the implants after 6 months and 12 months of implant placement with CBCT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Less crestal bone loss around the implants placed in thick mucosal tissue. |
crestal bone loss will be checked around the implants after 6 months and 12 months of implant placement with CBCT |
|
|
Target Sample Size
|
Total Sample Size="16" Sample Size from India="16"
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)
|
05/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/01/2025 |
| 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) |
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 - NO
|
|
Brief Summary
|
i) Rationale:
Peri-implantitis can be defined as a crestal bone loss / marginal
bone loss (MBL) equal to or greater than three millimeters in the presence of
clinical signs such as PPD > 6 mm and BOP. Although
MBL does not always lead to peri-implantitis, there is no peri-implantitis
without the prior presence of MBL. Berglundh et al. has related this to
thickness of soft tissues. They reported that in thin tissues formation of
gingival cuff after the second stage surgery resulted in significant bone
resorption, in contrast to the thick tissue group, where no statistically
reliable bone loss occurred. Hence, it seems that correlation
between the thickness of gingival tissue and subsequent bone loss around
implants does exist.
ii) Novelty:
Assesment in mucosal tissue thickness
classification given by Egreja et al in 2012. Marginal bone loss will be
measured using CBCT in SIDEXIS 4 software with SICATSUITE version 2.0. (Dentsp ly Sirona; York, US) immediately after
implant placement and 6 months later.
iii)
Objectives:
To evaluate and compare the MBL
around the implants placed in thin and thick mucosal tissue.
iv) Methods:
The mucosal tissue thickness will be assessed with transgingival
probing method given by Dimitrios Kloukos et al in 2021. Radiographic assessments for MBL around
the implant will be done immediately after implant placement, 6 months and 12 months later
using CBCT. MBL will be measured using SIDEXIS 4 software with SICATSUITE
version 2.0. (Dentsply Sirona; York, US)
v) Expected outcome:
Less
marginal bone loss in thick mucosal tissue as compared to thin mucosal tissue. Hypothesis:
In thin and thick mucosal tissue there might
be marginal bone loss or no marginal bone loss around the implant
|