| CTRI Number |
CTRI/2024/11/077494 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effects of using two types of dental implant systems on surrounding gums and bone |
|
Scientific Title of Study
|
Comparative evaluation of Peri-implant marginal tissues in soft tissue-level versus bone level implants – a randomized split-mouth 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 |
Arvind R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education, Manipal |
| Address |
Dept Of Oral and Maxillofacial Surgery
Manipal College of Dental Sciences
Lighthouse Hill Road Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09845794666 |
| Fax |
|
| Email |
arvind.r@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Shobha J Rodrigues |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education Manipal |
| Address |
Department of Prosthodontics and Crown and Bridge
Manipal College of Dental Sciences
Lighthouse Hill Road Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448100464 |
| Fax |
|
| Email |
shobha.j@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shobha J Rodrigues |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences Mangalore Manipal Academy of Higher Education Manipal |
| Address |
Department of Prosthodontics and Crown and Bridge
Manipal College of Dental Sciences
Lighthouse Hill Road Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448100464 |
| Fax |
|
| Email |
shobha.j@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences Mangalore
Manipal Academy of Higher Education Manipal
Lighthouse Hill Road
Mangalore 575001
Karnataka India |
|
|
Primary Sponsor
|
| Name |
Arvind R |
| Address |
Dept Of Oral and Maxillofacial Surgery, Manipal College of Dental Sciences, Lighthouse Hill Road Mangalore 575001 |
| 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 Arvind R |
Manipal College of Dental Sciences Mangalore |
Department of Implantology,
Room number 5
Manipal College of Dental Sciences
Lighthouse Hill Road Mangalore
Dakshina Kannada
KARNATAKA |
9845794666
arvind.r@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Manipal College of Dental Sciences Mangalore |
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 |
Bone level implant |
Bone level endosseous implant insertion and restoration with screw retained crown after 3 months |
| Intervention |
Soft tissue level implant |
Endosseous implant insertion followed by restoration with screw retained crown after 3 months |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients requiring implant insertion in premolar-molar region of right & left side of jaw located contiguous to natural teeth, tooth-bound edentulous space
Healed implant sites with adequate osseous architecture, thick gingival biotype
Absence of antibiotic therapy in the previous three months
Nondiabetic (HbA1c less than 6.0 percent), Vit D more than 20ng per ml
Signed informed consent and willing to come for follow up |
|
| ExclusionCriteria |
| Details |
Absence of keratinized tissue or need for crestal bone augmentation of implant site
Diagnosis or History of periodontitis
Systemic conditions contraindicating surgery, infectious diseases, medications influencing bone metabolism, immune modulators, previous pathologic conditions, bruxism, SSRI
Pregnancy and lactation
Smoking |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Marginal bone loss around soft tissue level and bone level implants |
6,12,18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Probing depth, Plaque Index and Bleeding on probing around soft tissue level and bone level implants |
6,12,18 months |
| Submucosal microbiota using real time PCR around soft tissue level and bone level implants |
6,18 months |
| Matrix metalloproteinase (MMP) in peri implant crevicular fluid around soft tissue level and bone level implants |
6, 18 months |
| Comparative metabolomics of peri implant crevicular fluid around soft tissue level and bone level implants |
6,18 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
09/12/2024 |
| 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="4"
Months="0"
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
|
Research Question - Does the choice of Soft tissue level (STL) or Bone Level (BL) implant impact per implant tissues when patient related, surgery related, and prosthesis related variability is controlled? Null hypotheses 1 There is no difference in the Means of clinical, microbial, biomarker and metabolomic measures from peri implant tissues around soft tissue level and bone level implants 2 There is no correlation between clinical indices, microbiota, biomarkers and metabolites and soft tissue level or bone level implants Aims 1 To conduct prospective split mouth trial to compare soft tissue level and bone level implants 2 to perform comprehensive clinical, microbial, biochemical and metabolomic evaluation Trial design Prospective split mouth randomized controlled clinical trial
|