A study to compare the early osseiontegration between photofunctionalized and non photofunctionalized titanium dental implant in the mandibular region – A randomized controlled trial

Patients fulfilling the eligibility criteria will be chosen for the study. All the patients will be explained about the procedures involved and those willing to be part of the study will be enrolled. A written voluntary informed consent will be obtained from the willing subjects. A case proforma will be made to record the history the associated signs and symptoms.

 The subjects will be equally divided in 2 groups on the basis of age 25 to 32 years and 33 to 40 years. 6 patients from each group will further be divided equally into 3 male and 3 female subgroups. The subjects will be sent to control and experiment group randomly. In order to pre decide the appropriate length and diameter of the implants, participants have to undergo a CBCT scan prior to the surgery. The patients will also be divided on the basis of grayscale value which will be used in future to stratify the patient according to bone density. The surgical site will be classified into three bone quality groups (2,3,4) on the basis of the objective evaluation of the grayscale value measured on CBCT scans. The grayscale value above 500 will be classified as bone quality group 2, between 300 to 500 as group 3, and below300 as group 4. The clinician will receive implant fixture/fixtures which is selected for each surgical case. The procedure will be conducted for each patient. The fixture for a participant who needs multiple implant placement will be included in the same group. Hence, the study is implant-based rather than patient-based.

In case of the photofunctionalized group the implant fixtures will be irradiated with a UV machine (DIO UVirradiator) for 20 seconds, so that the desired condition as per the manufacturer’s recommendation is achieved. After that, the implants will be delivered to the clinician. The placement of implant will be conducted according to the conventional procedures. Immediately after the surgery, the implant site will be evaluated using the Intra Oral Periapical radiograph.The stability of the implant will be assessed using the resonance frequency analysis device (OSSTELL MENTOR), and the Implant stability quotient value (ISQ) will be recorded. The ISQ will be measured immediately after placing the implant, 4 weeks ,8 weeks and 4 months post operatively.

 The intra oral periapical radiograph will be taken immediately after placing the implant, 8 weeks and 4 months post operatively using the paralleling technique (70KV, 6mA, 120millisecond). The digital radiograph sensor will be placed parallel to the long axis of the implant and the x-ray beam is directed perpendicular to the receptor to visualize the pitches and platform of the fixtures on the radiograph. A specialist who is trained in dental radiography will then evaluate the marginal bone level of the implants in each intraoral periapical radiograph. At first, the whole length of the fixtures will be measured for magnification calibration of the radiographs. After that, the distance from the platform of the fixture to the marginal bone crest is recorded both mesially and distally. The difference between the measured value as compared to the initial value (the value obtained immediately after the surgery) will be calculated for each case and will be considered as bone loss. The mesial and distal bone loss will be calculated separately and will be recorded as mesial and distal marginal bone loss separately for each implant. At 4 months, a reverse torque of 30N will be given to both photofunctionalized and non photofunctionalized implant using torque wrench and implant resistance will be checked. Peri-implant soft tissue evaluation will be done at 8 weeks and 4 months after placement of implants. The soft tissue evaluation will be done using mouth mirror and plastic probe around using Mombelli et al (mGI).

procedures. Immediately after the surgery, the implant site will be evaluated using the Intra Oral Periapical radiograph.

The stability of the implant will be assessed using the resonance frequency analysis device (OSSTELL MENTOR), and the Implant stability quotient value (ISQ) will be recorded. The ISQ will be measured immediately after placing the implant, 4 weeks ,8 weeks and 4 months post operatively.

 The intra oral periapical radiograph will be taken immediately after placing the implant, 8 weeks and 4 months post operatively using the paralleling technique (70KV, 6mA, 120millisecond). The digital radiograph sensor will be placed parallel to the long axis of the implant and the x-ray beam is directed perpendicular to the receptor to visualize the pitches and platform of the fixtures on the radiograph. A specialist who is trained in dental radiography will then evaluate the marginal bone level of the implants in each intraoral periapical radiograph. At first, the whole length of the fixtures will be measured for magnification calibration of the radiographs. After that, the distance from the platform of the fixture to the marginal bone crest is recorded both mesially and distally. The difference between the measured value as compared to the initial value (the value obtained immediately after the surgery) will be calculated for each case and will be considered as bone loss. The mesial and distal bone loss will be calculated separately and will be recorded as mesial and distal marginal bone loss separately for each implant. At 4 months, a reverse torque of 30N will be given to both photofunctionalized and non photofunctionalized implant using torque wrench and implant resistance will be checked. Peri-implant soft tissue evaluation will be done at 8 weeks and 4 months after placement of implants. The soft tissue evaluation will be done using mouth mirror and plastic probe around using Mombelli et al (mGI).