Clinical trial NCT06444334: Laser Biostimulation on Implant Covered With PRF in Controlled Diabetics
Official title: Evaluation of the Effect of Laser Biostimulation on Implant Covered With PRF in Controlled Diabetic Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Implant Site Reaction
Platelet Rich Fibrin
Keywords: laser biostimulation
PRF
implants
osseointegration
diabetic patient
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 22 implants were divided randomly into 2 groups. Group1: control group (no laser irradiation), group2: diode laser irradiation group
Primary purpose: SUPPORTIVE_CARE

Brief summary: the goal of this clinical trial is to evaluate laser biostimulation effect on osseointegration of implant covered by PRF(platelet rich fibrin) in controlled diabetic patients with compromised healing potential.

METHODS: The study was conducted on type 2 controlled diabetic patients receiving 22 implants covered with PRF inserted in posterior maxilla or mandible. Implants were divided randomly into 2 groups. Group1: control group (received no laser irradiation), group2: received diode laser. Peri-implant new bone density and secondary stability were assessed using cone-beam computed tomography and Anycheck device respectively. Density was evaluated immediately post implant insertion and after 5 months, while implant stability was performed 5 months post implant insertion. Statistical analysis was executed significance level P ≤ 0.05.

Detailed description: Study type:

randomized controlled clinical trial.

Study design:

Controlled type II diabetic patients with edentulous posterior areas were randomly selected from dental clinic of Medical and Scientific Centre of Excellence (MSCE), National Research Centre (NRC), Cairo, Egypt, according to inclusion and exclusion criteria to receive a total number of twenty-two dental implants. Implants were randomly distributed with 1:1 allocation ratio into two groups according to exposure to laser irradiation. Group 1 was not exposed to laser irradiation (control group), while group 2 was exposed to laser irradiation. Peri-implant new bone density was evaluated immediately post implant insertion and after 5 months, while secondary implant stability was performed 5 months post implant insertion.

This study was prosecuted with the Code of Ethics of the World Medical Association, they were stated in the Declaration of Helsinki in 1975. Medical Research Ethical Committee of the National Research Centre, Cairo, Egypt permitted this study with approval number (03430423). All patients were familiar with the study's treatment phases and signed a consent form. The study was conducted from January 2023 to March 2024

Radiographic procedures:

Every patient had undergone radiographic analysis pre-operatively using cone beam computed tomography (CBCT) . The intended size and location of the implants were determined and planned virtually by digital software (Planmeca Romexis Viewer 6.2.1.19). Bone density around the implants will be evaluated using CBCT software at (immediately postoperative as baseline and 5 months postoperative. Both groups were radiographed by cone beam CT for evaluation and assessment of bone density around implants by professional blinded investigators. Planmeca Romaxies machine was used with the following specifications: Field of View (FOV) = 8.0x5.0 cm, resolution = 0.300, orientation = portrait, 90 kV, 80mA, and exposure time = 15.019 sec.

Surgical procedures:

Implants (K1 line conical connection double thread, OXY, Italy) were inserted under profound local anesthesia using free hand open flap technique; where mucoperiosteal gingival envelop full thickness flap was performed by crestal incision \& mucoperiosteal reflection exposing bone . The preplanned location was confirmed by the aid of CBCT, then sequential drilling was exerted using graduated drills with stoppers under copious amount of saline coolant with the aid of paralleling pins if multiple implants were inserted to be splinted in the same patient.

Implants were screwed with torque between 35-45N to ensure primary stability. Various implants' sizes were utilized ranging from 4 mm to 5.5mm in diameter and from 8mm to 11mm in length in accordance with the virtual pre-plan based on bone geometrical availability. The procedure was executed by a single well-experienced operator who was blinded to the groups.

PRF preparation protocol:

The preparation method of PRF was performed in accordance with the protocol developed by Choukroun. PRF was withdrawn and processed from the same operated-on patient's blood; 6ml IV blood withdrawn from the antecubital vein in to two sterile 3ml red vacutainer tubes without anticoagulant, followed by a 12 minute centrifuge with 3000 RPM producing a platelet rich fibrin clot, which is then incised \& separated with 2mm basal layer of RBCs rich in growth factors . Following the cover screw placement, PRF was extended bucco-lingually and mesio-distally over the alveolar ridge . Finally, approximation of the flap was achieved using non-resorbable 3/0 suture which was removed after 7-10 days postoperative. Nonsteroidal anti-inflammatory drugs and antibiotics were administered for seven days. Delayed loading was initiated after 5 months of osseointegration process.

Laser irradiation protocol:

Group 2 was exposed to laser irradiation following implant insertion for 3 sessions: Immediately after implant insertion, 2 days after implant insertion and 1 week after insertion , using a red Diode(gallium-aluminum-arsenide) LLLT using calibrated diode laser device at 635nm wavelength delivered by biomodulating handpiece with the following set parameters: 100mw power output, 8mm handpiece diameter, continuous mode, and time 40 second per point and contact mode . The laser probe was directed towards the implant site, gently touching the tissues mesially, distally, buccally, and lingually to assure the full exposure of the target surface to laser beam.

Eligibility criteria: Inclusion Criteria:

1. nonsmoker patients,
2. age range 30 -60 years,
3. Glycosylated hemoglobin (Hb1C) ranges between 7-8,
4. no other systemic disease,
5. vital signs are normal (blood pressure, temperature, pulse rate, respiratory rate),
6. missing 1st or 2nd mandibular or maxillary premolars or molars,
7. lab investigations are within normal (CBC. liver function AST \&ALT, kidney function urea \&creatinine, Ca level, 25OH Vit D),
8. no need for alveolar bone grafting, and
9. no soft or hard tissue pathology.

Exclusion Criteria:

1. smoker patient,
2. Glycosylated hemoglobin (Hb1C) more than 8 or less than 7,
3. age less than 30 or more than 60,
4. presence of other systemic diseases,
5. vital signs are not normal,
6. lab investigations are not normal (CBC, liver function, kidney function),
7. need for alveolar bone grafting and
8. present soft or hard tissue pathology.

Primary outcomes:
measure: Per-implant bone density measurements
timeFrame: at immediate day of surgery(baseline) and after 5 months for the same patients
Secondary outcomes:
measure: Implant stability measurements
timeFrame: only after 5 months from implant insertion
Other outcomes:
Locations:
city: Guiza
country: Egypt
facility: Oral Surgery Clinic at National Research Centre
Study officials:
affiliation: National Research Centre, Egypt
name: Noha M Ismael, PhD
role: STUDY_DIRECTOR
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