| CTRI Number |
CTRI/2025/11/097525 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of maxillary anterior teeth cervical cross sections and dimensions for optimal anatomic healing abutments |
|
Scientific Title of Study
|
Assessment of maxillary anterior teeth cervical cross sections and dimensions for optimal anatomic healing abutments: A CBCT 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 Abhay Kolte |
| Designation |
Dean and HOD |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104, Department of Periodontics and Implantology Ranjeet Deshmukh 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 Kolte |
| Designation |
Dean and HOD |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104, Department of Periodontics and Implantology Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Hingna road Nagpur 440019 Maharashtra India
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Dean and HOD |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104, Department of Periodontics and Implantology Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Hingna road Nagpur 440019 Maharashtra India
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhay Kolte |
| Address |
Ranjeet Deshmukh Dental College and Research Centre Nagpur440019 |
| Type of Sponsor |
Other [None] |
|
|
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 Kolte |
Ranjeet Deshmukh dental college and research centre |
104 Department of Periodontics and Implant Dentistry
Nagpur
MAHARASHTRA |
9011071467
drabhaypkolte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontally and systemically healthy participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age range: Participants aged 18 to 60 years.
2.CBCT image quality: Clear CBCT images without metal artifacts.
3.Healthy maxillary anterior dentition without any restoration or prosthesis.
4.Participants must not have periodontitis or any other significant periodontal pathology.
|
|
| ExclusionCriteria |
| Details |
1.Congenital malformations or irregular anatomical structures affecting the maxillary anterior teeth.
2.Participants with significant malocclusion that could alter cervical contour measurements.
3.Conditions that may affect bone metabolism or dental development.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the cervical cross sections and dimensions of maxillary anterior teeth as assessed by CBCT and study the variations based on gender and dental arch morphology. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To analyse genderbased differences in cervical cross sections and dimensions as assessed by CBCT.
2.To evaluate the influence of dental arch morphology on cervical cross-sections and dimensions as assessed by CBCT.
3.To assess variations in different maxillary anterior teeth as assessed by CBCT.
4.To establish a morphological database for anatomic healing abutment prefabrication.
5.To explore the clinical significance of CBCT-based cervical measurement.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/11/2025 |
| 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="0"
Months="6"
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
|
Successful implant therapy in the anterior maxilla relies not only on osseointegration but also on the establishment of an optimal peri-implant soft tissue profile. Conventional healing abutments with circular or symmetrical designs often fail to replicate the natural cervical anatomy of maxillary anterior teeth, leading to compromised esthetic outcomes. Cone Beam Computed Tomography (CBCT) offers a precise method for evaluating tooth cervical morphology, enabling the design of anatomically contoured healing abutments that may improve soft tissue adaptation. Aim: To assess the cervical cross-sections and dimensions of maxillary anterior teeth using CBCT and to evaluate variations based on gender and dental arch morphology, with the goal of creating a morphological database for anatomically guided healing abutments. Methodology: This cross-sectional study will include 60 participants (30 males, 30 females) aged 18 to 60 years, with healthy maxillary anterior dentition. CBCT scans will be analyzed to measure mesiodistal and buccopalatal widths, cervical perimeter, cross-sectional area, 3D cervical volume, and emergence profile angle. Expected Outcomes: The study aims to identify gender- and arch-related variations in cervical morphology of maxillary anterior teeth, establish a reference database, and provide guidelines for the design of preformed anatomic healing abutments. These findings are expected to enhance peri-implant soft tissue shaping and improve esthetic and functional outcomes in implant restorative procedures. |