| CTRI Number |
CTRI/2018/04/013368 [Registered on: 19/04/2018] Trial Registered Prospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This is a prospective radiographic (CBCT) study to assess buccal and lingual bone thickness of maxillary and mandibular posterior region at dentate sites |
|
Scientific Title of Study
|
Assessment of buccal and lingual bone thickness of maxillary and mandibular posterior region at dentate sites a CBCT study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay P Kolte |
| Designation |
Professor and HOD |
| Affiliation |
MDS |
| Address |
Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Professor and HOD |
| Affiliation |
MDS |
| Address |
Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Professor and HOD |
| Affiliation |
MDS |
| Address |
Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhay P Kolte |
| Address |
Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills Hingna road
Nagpur 440019
Maharashtra India
|
| 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 Abhay P Kolte |
VSPM Dental College and Research Centre, Digdoh hills, Nagpur, Maharashtra |
Department of Periodontics and Implantology
Nagpur
MAHARASHTRA |
9011071467
drabhaypkolte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontally healthy males and females |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants of both genders equally divided
2. Participants between 20 to 50 years of age
3. Patients with healthy periodontal conditions
|
|
| ExclusionCriteria |
| Details |
1. Individuals with prosthesis
2. Presence of inflammation at the apical level
3.Tooth malalignment
4. The presence of restorations or root canal treatment
5. CBCT with distorted images of the cementoenamel junction or bone crest
6. Cases with buccal bone loss greater than or equal to 3 mm from the CEJ
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse the anatomical dimensions of the buccal and lingual bone wall thickness of the dentate posterior maxillary and mandibular region using CBCT scans |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate dimensions of buccal bone wall thickness of teeth mesial and distal to edentulous space in patients requiring implant placement using CBCT scans
and dimensions of lingual bone wall thickness of teeth mesial and distal to edentulous space in patients requiring implant placement using CBCT scans
and compare the dimensions of buccal and lingual bone wall thickness of teeth mesial and distal to edentulous space between males and females requiring implant placement using CBCT scans
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
23/04/2018 |
| Date of Study Completion (India) |
22/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Sent for publication. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Background: Alveolar bone dimensions form an important prognostic factor in determining the success of implant treatment outcome.
Aim:The present study evaluated the buccal and lingual bone width in posterior dentate and edentulous sites using cone‑beam computed tomography (CBCT).
Materials and Methods: The study included 100 patients, divided equally into two groups, Group A (males) and Group B (females) indicated for implant therapy. CBCT scans were evaluated for the assessment of the thickness of buccal and lingual bone width at four levels, i.e., crestal bone width (CBW), mid root bone width, middle of alveolar bone housing bone width , and most apical portion bone width (APBW). Bone width was measured at three levels in the edentulous region as CBW, bone width 5 mm from crest (CBW‑1), and 10 mm from crest (CBW‑2).
Results: Gradual increase in bone width was observed from crestal bone at buccal and lingual level (CBW‑B and CBW‑L) from 1.10 ± 0.29 mm and 1.21 ± 0.34 mm to APBW at buccal and APBW lingual side from 2.82 ± 0.51 mm and 3.43 ± 0.42 mm, respectively. For both the groups, the differences in bone width at three levels were statistically significant, with CBW being significantly higher for Group A than Group B.
Conclusion: At edentulous sites, CBW was lesser as compared to the apical levels. The bone width on buccal and lingual sides of dentate sites at the coronal level is minimal compared to the apical level, which has definite implications for implant therapeutics. |