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CTRI Number  CTRI/2025/07/090270 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 05/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparing Gum and Bone Healing When Dental Implants Are Used Immediately vs After a Few Weeks A Study in Real Patients 
Scientific Title of Study   A comparative study on peri-implant bone levels and soft tissue changes between immediate and early functional loaded implants- 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  D Praveen 
Designation  Post graduate 
Affiliation  Bapuji dental college and hospital 
Address  Bapuji dental college and hospital department of prosthodontics crown and bridge room number 07 MCC B Block Davanagere

Davanagere
KARNATAKA
577004
India 
Phone  7975319375  
Fax    
Email  drdpraveen4154@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dhanya Kumar B H 
Designation  Professor 
Affiliation  Bapuji dental college and hospital 
Address  Bapuji dental college and hospital department of prosthodontics crown and bridge room number 07 MCC B Block Davanagere

Davanagere
KARNATAKA
577004
India 
Phone  9886000211  
Fax    
Email  budihal73@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dhanya Kumar B H 
Designation  Professor 
Affiliation  Bapuji dental college and hospital 
Address  Bapuji dental college and hospital department of prosthodontics crown and bridge room number 07 MCC B Block Davanagere

Davanagere
KARNATAKA
577004
India 
Phone  9886000211  
Fax    
Email  budihal73@gmail.com  
 
Source of Monetary or Material Support  
Bapuji dental college and hospital department of prosthodntics crown and bridge 
 
Primary Sponsor  
Name  self 
Address  Bapuji dental college and hospital department of prosthodontics crown and bridge room number 07 MCC B Block Davanagere 
Type of Sponsor  Other [private dental college and hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
D Praveen  Bapuji dental college and hospital  room number 07 department of prosthodontics crown and bridge MCC B Block
Davanagere
KARNATAKA 		 7975319375

drdpraveen4154@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bapuji dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  early functional loaded implants  if primary stability of implant is from 65 to 69 then early functional loading of implant is done for the patient and the mean bone loss , modified gingival index , modified plaque index will be evaluated at baseline,3 months and 6 months. 
Intervention  immediate functional loading of implant  if primary stability of implant is greater than or equal to 70 then immediate functional loading of implant is done for the patient and the mean bone loss , modified gingival index , modified plaque index will be evaluated at baseline,3 months and 6 months. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Single implant should be placed within the age group between 25 to 50 years
ISQ value greater than or equal to 70 for Immediate loading
ISQ value 65 to 69 for Early functional loading
Healthy remaining dentition where RPI score should be within 0 to 0.2
Good oral hygiene where OHI-S score should be within 0 to 1.2
No retained roots or pathologic lesions
Adequate inter arch clearance for implant abutment which should be within 8 to 12mm
Adequate quality D1 D2 D3 and quantity of bone for implant placement
Patient should be available for follow-up

 
 
ExclusionCriteria 
Details  Systemic illness or metabolic condition that may affect research pregnant women or nursing mothers
Recipient site pathosis
Over erupted opposing teeth
Parafunctional habits
Smokers
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
peri implant mean bone loss   baseline, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
modified gingival index  3 months, 6 months 
modified plaque index  3 months, 6 months 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
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/ Phase 4 
Date of First Enrollment (India)   07/08/2025 
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="9"
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  

Need for the Study:
Replacing lost natural teeth with osseointegrated implants is now seen as a major advance in prosthetic dentistry. Traditional tooth replacement methods are gradually being replaced by implants due to their high success rates, earning them the title of the third dentition. In 1990, studies first suggested that implants could be loaded early or immediately, especially in mandibles with good bone quality. According to Misch et al., implant loading can be delayed, early, or immediate. Delayed loading keeps implants unloaded for 3 to 6 months. Early loading places a temporary prosthesis between 2 weeks and 3 months after placement, which can be functional or nonfunctional. Immediate loading places a temporary prosthesis on the day of surgery or within 2 weeks. The choice of protocol depends mainly on primary stability, measured by the Implant Stability Quotient (ISQ). ISQ values greater than or equal to 70 indicate high stability suitable for immediate loading. ISQ between 65 and 69 indicates medium stability suitable for early functional loading. Immediate loading aims to reduce treatment time while maintaining hard and soft tissue, offering an alternative approach to shorten patient discomfort and waiting time.

Objectives:

  1. To compare peri-implant bone loss between immediate and early functional loaded implants at 3 and 6 months.
  2. To compare the modified gingival index at 3 and 6 months.
  3. To compare the modified plaque index at 3 and 6 months.

Research Question:
Is there any difference in peri-implant bone levels and soft tissue changes between immediate and early functional loaded implants at 3 and 6 months?

Hypothesis:
H1: There is a significant difference.
H0: There is no significant difference.

Materials and Methods:
The study is a prospective study conducted at the Department of Oral Implantology, Bapuji Dental College and Hospital, Davangere. Informed consent will be obtained from all participants.

Inclusion Criteria:
Patients aged 25 to 50 with single implants, ISQ greater than or equal to 70 for immediate loading, ISQ 65–69 for early loading, healthy dentition, good oral hygiene, no retained roots or pathology, adequate bone and interarch clearance, and availability for follow-up.

Exclusion Criteria:
Systemic illnesses, metabolic conditions, pregnancy, nursing mothers, recipient site pathosis, over erupted opposing teeth, parafunctional habits, and smokers are excluded.

Sample Size:
The sample size was calculated using standard formulas with a standard deviation of 0.3 and expected means of 0.6 and 0.9. With a 5 percent Type I error and 80 percent power, the calculated size is 16. Considering 20 percent possible loss to follow-up, 18 subjects will be included, with 9 in each group.

Study Design:
Prospective study with two groups: Group A (immediate loading) and Group B (early functional loading), each with 9 patients.

Equipment:
ISQ device (OSTELL), X-ray machine, hand torque instruments, plastic probe, digital intraoral periapical radiographs (IOPAR).

Procedure:
Eligible patients will undergo blood investigations and CBCT. Implants will be placed under local anesthesia using standard surgical protocol. Primary stability will be assessed using ISQ. If ISQ greater than or equal to 70, the implant is immediately loaded and assigned to Group A. If ISQ is 65–69, the implant is early loaded and assigned to Group B. Group A will receive provisional crowns within 48 hours with no occlusal contact initially and light contact after 2 months. Group B will receive provisional crowns 1 week to 3 months after surgery with light occlusal contact from the start. Permanent prostheses will be placed at 4 months for both groups.

Follow-Up and Evaluation:
Intraoral radiographs will be taken immediately, at 3 months, and at 6 monthTop of Form

STATISTICAL ANALYSIS:

Collected data will be entered in excel software and analyzed using R-software version 4.0.2 continuous variable will be presented as mean and standard deviation, categorical variable will be presented as count and percent. Independent t-test will be used to compare means of two groups. p less than 0.05 will be considered statistically significant.


 
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