| CTRI Number |
CTRI/2025/09/094492 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing custom-made and standard implant abutments to improve the appearance of front teeth in patients needing dental implants |
|
Scientific Title of Study
|
A comparative study of customized versus standard abutments on esthetic outcome in the maxillary anterior region |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aashita Boricha |
| Designation |
Postgraduate Student |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Prosthodontics and Crown and Bridge New Dental Building Near Gate no 2
King Georges Medical University
Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
7405010200 |
| Fax |
|
| Email |
aashitaboricha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamleshwar Singh |
| Designation |
Professor |
| Affiliation |
Faculty Of Dental Sciences, KGMU , Lucknow . |
| Address |
Department of Prosthodontics and Crown and Bridge
New Dental Building Near
Gate no 2 , Shah Mina Road,
King Georges Medical University
Lucknow
Pincode 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9236678094 |
| Fax |
|
| Email |
dr_kamleshwarsingh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Aashita Boricha |
| Designation |
Postgraduate |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Prosthodontics and Crown and Bridge New Dental Building Near Gate no 2
King Georges Medical University
Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
7405010200 |
| Fax |
|
| Email |
aashitaboricha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics and Crown and Bridge New Dental Building Near Gate no 2
King Georges Medical University
Lucknow U.P
INDIA
226003
|
|
|
Primary Sponsor
|
| Name |
Aashita Boricha |
| Address |
Department of Prosthodontics and Crown and Bridge New Dental Building Near Gate no 2
King Georges Medical University
Lucknow |
| Type of Sponsor |
Other [self funding] |
|
|
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 Aashita Boricha |
King Georges Medical University |
6th Floor
Department of Prosthodontics and Crown & Bridge Postgraduate Clinic
Lucknow.
Lucknow
UTTAR PRADESH |
7405010200
aashitaboricha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KingGeorgesMedicalUniversityU.P.InstitutionalEthicsCommitteeLucknow226003 |
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 |
| Intervention |
Customized Abutment |
Implants will be placed according to recommendations given by manufacturer
After 4 months, 2nd stage surgery performed, gingival former inserted and after 2 weeks digital scanning, fabrication of customized abutment and crown subsequently will be done and then delivered.
Will be observed at basline , 1,3,6,12 months |
| Comparator Agent |
Standard Abutment |
Implants will be placed according to recommendations given by manufacturer
After 4 months 2ndstage surgery performed, gingival former inserted after 2 weeks conventional impression is taken for standardized abutment group and subsequent crown will be fabricated and then delivered.
Will be observed at basline , 1,3,6,12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient with partial edentulous space in the anterior maxilla.
2 Patient between the age group of 18-65 years.
3 No disease of the oral mucosa, No local inflammation.
4 Extraction at least 3-4 months previously.
5 Sufficient bone volume at the implant site.
6 Patients with good oral hygiene.
7 Patient consenting to be a part of study.
|
|
| ExclusionCriteria |
| Details |
1 Patients with systemic diseases
(Such as cardiac, coagulation and leukocyte diseases or metabolic disorders)
2 History of radiotherapy to the head and neck
3 Current treatment with steroids( under systemic bisphosphonates)
4 Neurological or psychiatric disability that could interfere with treatment;
5 Immunocompromised status, including human immunodeficiency virus infected
6 Severe teeth grinding or bruxism;
7 Smoking habit ,drug or alcohol abuse
8 Pregnant / Nursing at the time of enrollment
9 Inadequate compliance.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Compare crestal bone level of customized with standard abutment. |
at basline,1,3,6,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluate customized and standard abutment association with soft tissue health.
2.Compare pink and white esthetic score between customized and standard abutment.
|
at basline,1,3,6,12 months |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
03/10/2025 |
| 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="1"
Months="0"
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
|
After medical/dental history, examination, radiographs, and informed consent, patients will receive prophylactic antibiotics (Amoxicillin 2 g 1 hr prior). Implants will be placed under local anaesthesia (2% Lignocaine with adrenaline) following standard surgical protocols.
At 4 months, second-stage surgery will be performed and gingival formers placed.
-
Customized abutment group: After 2 weeks digital scanning will be done customized abutments and crowns fabricated and delivered.
-
Standard abutment group: After 2 weeks conventional impressions will be made standard abutments and crowns fabricated and delivered.
Outcomes will be evaluated by
-
Probing depth around abutments,
-
Crestal bone loss (radiographically at baseline, 1, 3, 6, 12 months),
-
Esthetic outcome using Pink and White Esthetic Score.
|