| CTRI Number |
CTRI/2023/07/055458 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
17/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of stability of two types of dental implants placed for the management of edentulous space in healthy and diabetic individuals |
|
Scientific Title of Study
|
Evaluation of secondary stability in Healthy and Diabetic
individuals using conventional SLA implants and
Trabecular Tantalum implants. A Randomized controlled
trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geetha Arul Mohan |
| Designation |
Post graduate |
| Affiliation |
SRM university |
| Address |
SRM Dental College, Bharathi salai, Ramapuram, 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9943320006 |
| Fax |
|
| Email |
mail2algeetha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harinath Parthasarathy |
| Designation |
professor |
| Affiliation |
SRM university |
| Address |
SRM Dental College, Bharathi salai, Ramapuram, 600089
SRM Dental College, Bharathi salai, Ramapuram, 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9840482400 |
| Fax |
|
| Email |
hari_feb14@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Geetha Arul Mohan |
| Designation |
Post graduate |
| Affiliation |
SRM university |
| Address |
SRM Dental College, Bharathi salai, Ramapuram, 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9943320006 |
| Fax |
|
| Email |
mail2algeetha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, SRM Dental College |
|
|
Primary Sponsor
|
| Name |
Geetha Arul Mohan |
| Address |
SRM, Dental college, Ramapuram, Chennai, 600089 |
| Type of Sponsor |
Other [self funding] |
|
|
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 |
| Geetha Arul Mohan |
SRM Dental college |
SRM Dental College, Bharathi salai, Ramapuram, Chennai, 600089
Chennai
TAMIL NADU |
9943320006
mail2algeetha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of SRM Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparative agent- group 1 |
SLA implants will be placed in healthy individuals for management of edentulous sites in mandible
|
| Comparator Agent |
comparative agent- Group III |
SLA Implants will be placed in diabetic individuals for management of edentulous sites in mandible |
| Intervention |
intervention agent- Group II |
Trabecular implants will be placed in healthy individuals for management of edentulous sites in mandible |
| Intervention |
intervention agent- Group IV |
Trabecular implants will be placed in diabetic individuals for management of edentulous sites in mandible |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for diabetic individuals:
1. diabetic patients with HbA1C: 6.1-8 [Group III and group IV]
2. Patients who are between 18-60 years of age
3. All sites had to be healed sites, that is at least 6 months of post extraction healing was required
4. Mandibular edentulous sites
Inclusion criteria for healthy individuals:
1. Non diabetic patients with HbA1C- less than 6.1 [Group I and group II]
2. Patients who are between 18-60 years of age
3. All sites had to be healed sites, that is at least 6 months of post extraction healing was required
4. Mandibular edentulous sites
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria for diabetic individuals:
1. HbA1C levels exceeding 8 are excluded
2. History of oral /intravenous bisphosphonate use for >3 years
3. Smokers
4. Pregnancy or lactation
5. Known allergy to any material or medication used in the study
6. Any Previous History of head and neck radiation therapy
7. Chemotherapy in the last 12 months
8. Severe psychologic problems
9. Patient not willing to sign the consent approved by the Human Studies Committee
10. Debilitating systemic diseases or conditions that have a clinically significant effect on wound healing
Exclusion criteria for healthy individuals:
1. HbA1C levels exceeding 6.1 are excluded[Group I and group II]
2. History of oral /intravenous bisphosphonate use for >3 years
3. Smokers
4. Pregnancy or lactation
5. Known allergy to any material or medication used in the study
6. Any Previous History of head and neck radiation therapy
7. Chemotherapy in the last 12 months
8. Severe psychologic problems
9. Patient not willing to sign the consent approved by the Human Studies Committee
10. Debilitating systemic diseases or conditions that have a clinically significant effect on wound
|
|
|
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 |
| Evaluation of secondary stability using Resonance frequency analyser in healthy and diabetic individuals |
subjects will be followed at baseline, 2 and 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Primary stability and Crestal bone levels in healthy and diabetic individuals |
subjects will be followed at baseline, 2 and 4 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
17/08/2023 |
| 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
|
Not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Implants are a preferred choice in the treatment of edentulism. There are various factors including implant surface characteristics and wettability which decide successful osseointegration. Common problems faced by patients during conventional implant treatment includes long waiting time for successful osseointegration usually 3-4 months, which is further delayed in diabetics( upto 6 months). Even though immediate loading is practiced, uncertainties due to lack of biological osseointegration prevails, which posses unique challenges for the clinicians especially in medically compromised individuals with diabetes mellitus. Hence there is always a quest for new implant designs and superior surface characteristics for shortened osseointegration time and to reduce the overall treatment duration with special emphasis for diabetic patients. Resonance frequency analysis (RFA) is a predictable non invasive tool, for evaluating the primary and secondary stability in numerous study. a. Traditional protocols propose that the implant should receive no loading during the osseointegration period usually 3-4 months in healthy individuals which is further higher in diabetics resulting in longer waiting period for the patients without teeth and compromised overall quality of life. b. A successful osseointegration is based on many factors that influence the formation and maintenance of bone at the implant surface such as the implant micro and macro surface characteristics, bone quality, primary stability, absence of micro motion, absence of infection during healing, aseptic surgical protocol and patient’s systemic conditions. c. Presently various implants are available with superior surface modifications like SLA active and trabecular tantalum implants. These implant surfaces have shown faster osseointegration. d. The trabecular implants, With a high coefficient of friction (0.98), it provides excellent initial scratch fit. Unlike coatings and other surfaces, it has up to 80% porosity, enhancing the potential for bone ingrowth and soft tissue vascularization. With its nano-textured struct architecture, Trabecular implants are similar to cancellous bone in structure, function, and physiology. The Structure supports bone integration, bone remodeling and vascularization. These properties enhances the rate of osseointegration, thus reducing the overall treatment duration. |