| CTRI Number |
CTRI/2024/06/068805 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of missing teeth in patients with thin bone using two type of dental implants. |
|
Scientific Title of Study
|
Comparative evaluation of crestal bone loss between
SLA and RBM surface implants in Narrow Alveolar
ridges with Osseo densification technique - An
Observational clinical 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 |
Harini K |
| Designation |
First year Postgraduate Student |
| Affiliation |
SRM Dental College |
| Address |
Department of Periodontology, SRM Dental College,Bharathi salai,Ramapuram,Chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
8148146347 |
| Fax |
|
| Email |
hk6456@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harinath P |
| Designation |
Professor |
| Affiliation |
SRM Dental College |
| Address |
Department of Periodontology, SRM Dental College,Bharathi salai,Ramapuram,Chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
9840482400 |
| Fax |
|
| Email |
harinatp@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harinath P |
| Designation |
Professor |
| Affiliation |
SRM Dental College |
| Address |
Department of Periodontology, SRM Dental College,Bharathi salai,Ramapuram,Chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
9840482400 |
| Fax |
|
| Email |
harinatp@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Dental College,Ramapuram,Tamil Nadu,chennai 600089 |
|
|
Primary Sponsor
|
| Name |
Harini K |
| Address |
Department of Periodontology, SRM Dental College,Bharathi salai,Ramapuram,Chennai. |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM Dental College |
Third floor, Department of Periodontology,SRM Dental College, Ramapuram, Chennai 600089 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harini K |
SRM Dental College |
SRM Dental College,Department of Periodontology, 3rd Floor, Bharathi salai,Ramapuram,Chennai.
Chennai
TAMIL NADU |
8148146347
hk6456@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM DENTAL COLLEGE,INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K082||Atrophy of edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
RBM Implant Group |
RBM implants is placed under local anesthesia for the management of narrow alveolar ridge to evaluate the crestal bone loss,primary and secondary stability will be measured at 0 4 8 12 16 weeks. |
| Comparator Agent |
SLA Implant Group |
SLA implants is placed under local anesthesia for the management of narrow alveolar ridge to evaluate the crestal bone loss,primary and secondary stability will be measured at 0 4 8 12 16 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Narrow ridge 4-6mm (Moderate) - Tolstunov’s
classification of alveolar ridge width.
2. Patients who are between 20-55 years of age.
3. All sites had to be healed sites, that is at least 6 months
of post extraction healing was required |
|
| ExclusionCriteria |
| Details |
1.Pregnancy and lactating women
2.Smokers and HBA1c exceeding 6.3
3.Known allergry to any material or medication used in the study
4. Any previous history of head and neck radiation therapy
5.Chemotherapy in the last 12 months
6.Severe pyschologic problems
7.Patient not willing to sign the consent approved by the human tudies committee
8. Debilitating systemic diseases or conditions that have a clinically significant effect on without healing
9.History of oral or intravenous bisphosphonate use for more than 3 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of crestal bone loss between
SLA and RBM surface implants in narrow
alveolar ridge |
subjects will be followed at 0 4 8 12 16 weeks after implant
placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparison of primary stability between SLA and RBM surface implants in narrow alveolar ridges.
2.Comparison of secondary stability of SLA surface implants in narrow alveolar ridge using OD technique.
3. Comparison of secondary stability of RBM surface implants in narrow alveolar ridge using OD technique.
4. CBCT comparison of Ridge width changes from baseline with SLA implants using OD technique.
5. CBCT comparison of Ridge width changes from baseline with RBM implants using OD technique.
6. Comparison of buccal bone width changes from baseline with SLA implant in OD technique.
7. Comparison of buccal bone width changes
from baseline with RBM implant in OD technique,
|
subjects will be followed at 0 4 8 12 16 weeks after implant
placement |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
15/07/2024 |
| 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="1"
Months="2"
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
|
For optimal implant success, availability of adequate amounts of bone in terms of horizontal as well as vertical dimensions is the first requirement, but local conditions of edentulous alveolar ridges may be unfavorable for implant placement. The resorption patterns of alveolar bone after tooth loss or extraction due to trauma and, periodontal disease leads to unfavourable ride dimensions. The greatest amount of bone loss usually occurs in the horizontal dimension, mainly on the facial side of the ridge. There may also be loss of vertical ridge height, which has been reported to be the most pronounced on the buccal aspect. This resorption process results in a narrower and shorter ridge. Scipioni et al. suggests that wherever dental implants are placed, a minimum thickness of 1–1.5 mm of bone should remain on both buccal and lingual/palatal aspects of the implant(s) to ensure a successful outcome. This lead to look out for alterative procedures such as ridge expansion and ridge splitting using osteotomes, osseodensification using specialized surgical drills etc. Ridge expansion techniques have been suggested to expand the narrow alveolar ridge with implant placement in a single surgical visit. Expanding the alveolar ridge was suggested as an approach of implant site preparation using osseodensification (OD), a non-subtractive drilling technique. It makes use of burs (Densah) that are precisely made and rotate counter-clockwise to preserve bone volume and assist autograft compaction resulting in an outward strain from the osteotomy, which causes plastic deformation and expansion of the alveolar bone. Additionally, a narrow ridge could accommodate a greater implant diameter without inducing fenestration or bone dehiscence by adopting the OD method. Densah burs are all examples of modern ridge expansion instruments. Presently various implants are available with surface modifications like SLA and traditional RBM surface treatments. These implant surfaces have shown optimal long term success. However crestal bone loss after implant placement and restoration poses greater challenges to clinicians especially in narrow ridge situation. There is a lacunae in literature evidences on comparison of crestal bone level changes between SLA and RBM surface implants in narrow ridges expanded with osseodensification techniques. Hence current study is designed to evaluate the crestal bone level changes between SLA and RBM surface implants placed in Narrow Alveolar ridges by Osseodensification technique |