A comparative study on peri-implant bone levels and soft tissue changes between immediate and early functional loaded implants- An in vivo study

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.