| CTRI Number |
CTRI/2024/09/074283 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To look for various options to adapt gums around the implants for natural looking crowns . |
|
Scientific Title of Study
|
Investigating the Impact of tailored healing abutment and abutment variations on peri-implant soft tissue contour in immediate implant placement with delayed loading: An In vivo 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 |
Priyanka Arora |
| Designation |
PG Student |
| Affiliation |
SGT University |
| Address |
Room no. 103, Department of prosthodontics, crown and bridge and oral implantology, Faculty of Dental Sciences, SGT university, Budhera, Gurugram Badli Road
Gurgaon
HARYANA
122505
India |
| Phone |
9717557591 |
| Fax |
|
| Email |
priyanka.arora1095@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reshu sanan |
| Designation |
Professor |
| Affiliation |
SGT University |
| Address |
Room no. 103, Department of prosthodontics, crown and bridge and oral implantology, Faculty of Dental Sciences, SGT university, Budhera, Gurugram Badli Road
Gurgaon
HARYANA
122505
India |
| Phone |
9910063626 |
| Fax |
|
| Email |
reshu.sanan@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Arora |
| Designation |
PG Student |
| Affiliation |
SGT University |
| Address |
Room no. 103, Department of prosthodontics, crown and bridge and oral implantology, Faculty of Dental Sciences, SGT university, Budhera, Gurugram Badli Road
Gurgaon
HARYANA
122505
India |
| Phone |
9717557591 |
| Fax |
|
| Email |
priyanka.arora1095@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no.103,Department of prosthodontics, crown and bridge and oral implantology, Faculty of Dental sciences, SGT University ,Budhera ,Gurugram Badli Road, Gurugram Harayana Gurgaon
HARYANA
122505
INDIA |
|
|
Primary Sponsor
|
| Name |
Priyanka Arora |
| Address |
Room no. 103, Department of prosthodontics, crown and bridge and oral implantology, Faculty of Dental Sciences, SGT university, Budhera, Gurugram Badli Road, Gurugram, Haryana
Gurgaon
HARYANA
122505
INDIA
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrPriyanka Arora |
SGT University |
Room no. 103, Department of prosthodontics, crown and bridge and oral implantology, Faculty of Dental Sciences, SGT university, Budhera, Gurugram Badli Road, Gurugram Haryana Gurgaon
HARYANA
Gurgaon
HARYANA |
9717557591
priyanka.arora1095@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-SGT Dental College, Hospital and Research Institute (IEC-SGTDCHRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
customized healing abutments |
checking the effect of customized healing abutments and various abutments on the peri implant soft tissue |
| Comparator Agent |
stock gingival former |
comparing the effect of stock gingival former and stock abutment on the peri implant soft tissue with customized gingival former |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Good oral hygiene.
Patient in the age group of 18-55 years.
â Patients requiring single tooth replacement with immediate implant placement.
â Mesio-distal width of 8 mm or less.
â Presence of adjacent teeth and antagonist teeth in alignment with absence of tilting / supra-eruption |
|
| ExclusionCriteria |
| Details |
According to ASA Classification Class 4 patients:
â Heart disease with marked signs of cardiac insufficiency.
â Recent myocardial infarction of less than 6 months duration.
â Unstable angina.
â Patients with advanced degrees of pulmonary, renal or endocrine insufficiency. â
Severe cardiac valvular dysfunction â
Sepsis
â Disseminated intravascular coagulation
According to ASA Classification class 3 patients: â Uncontrolled diabetes with complications to vascular or other organs i.e. retinopathy, neuropathy etc.
Active hepatitis
â Implanted pacemaker
â Immunocompromised patients
  â Blood dyscrasias
  â Occlusal anomalies
â Deep Bite
â Cross Bite
Para-functional habits
Bruxism
 â â Radiation therapy in orofacial region
  â Heavy smokers (more than 10 cigarettes per day)
 â â Alcohol abusers
  â Recent history of any acute illness
 â â Patients having unrealistic expectations and
psychological problems.
â â Local factors:
â Teeth associated with large periapical lesions (granuloma & cyst)
â â Periodontally compromised teeth with one or more bony wall defects
â â Presence of dehiscence or fenestrations of residual bony walls
â â Insufficient inter-arch space
â â Intraoral draining sinus in relation to the proposed implant site
â Perforation and/or loss of labial bony plate during extraction
â Unfavourable implant axis orientation
â â Patients with TMJ disorders
â â Thin gingival tissue biotypes |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will come to know which type of healing abutment gives best emergence profile . |
First scan will be done at Baseline -at o month during implant placement.
Second scan will be done at 3 months (during loading) &
Third Scan will be done 3 months post loading. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We will look for bleeding index & plaque index. |
First time point is at o month during implant placement
second time point is at 3 months during loading & third time point is 3months post loading
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/10/2024 |
| 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="2"
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
|
The peri-implant soft tissue attachment is not only important for the aesthetics but also for the success of the implant . The aim of the study is to investigate the impact of tailored healing abutment and abutment variations on peri-implant soft tissue contour in immediate implant placement with delayed loading . The study is designed to fulfill 4 objectives- 1. To evaluate the effect of stock gingival former and stock abutment on the peri-implant soft tissue contour in immediate implant with delayed loading . 2.To evaluate the effect of stock gingival former and customized abutment on peri implant soft tissue contour in immediate implant with delayed loading . 3.To evaluate the effect of customized gingival former and customised abutment on peri implant soft tissue contouring immediate implant with delayed loading . 4. To compare the soft contour around the implant pre and post use of varied customized healing abutments and final prosthesis. |