Laser Biostimulation on Implant Covered With PRF in Controlled Diabetics

NCT06444334 | Completed DMC

• 1 other identifier: 03430423
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Implant Site Reaction; Platelet Rich Fibrin

Keywords

laser biostimulation; PRF; implants; osseointegration; diabetic patient

Outcome Measures

Primary Outcomes (1)

• Per-implant bone density measurements

  Digital software program was used for quantitative mean bone density measurements of all the captured radiographs produced by CBCT for both groups. Multiplanar resolution screen (MPR) was selected showing radiographic images of the mandible and maxilla in sagittal and coronal views to quantify bone radiodensity in mesiodistal and buccolingual surfaces respectively , a constant exact area was selected for each view with area =1 5.2mm2, width = 2.00mm, and height = 7.60mm. Five readings of radiodensity in Hounsfield units (HU statistics) were collected by blind investigator for each peri-implant surface (mesial, distal, buccal, and lingual) with slice thickness of 0.5mm. Finally, the mean density values were calculated and tabulated concerning sagittal and coronal views in each implant

  at immediate day of surgery(baseline) and after 5 months for the same patients

Secondary Outcomes (1)

• Implant stability measurements

  only after 5 months from implant insertion

Study Arms (2)

control PRF group

ACTIVE COMPARATOR

controlled diabetic patients with 11 implants covered with PRF inserted in posterior maxilla or mandible, not laser irradiated

Procedure: PRF platelet rich fibrin

laser and PRF test group

EXPERIMENTAL

controlled diabetic patients with 11 implants covered with PRF inserted in posterior maxilla or mandible, expoed to Diode laser irradiation

Radiation: low level Diode Laser; Procedure: PRF platelet rich fibrin

Interventions

low level Diode Laser RADIATION

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-aluminun-arsenide) LLLT using calibrated diode laser device

laser and PRF test group

PRF platelet rich fibrin PROCEDURE

The preparation method of PRF was performed in accordance with the protocol developed by Choukroun et al 2001. 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

control PRF group; laser and PRF test group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

Oral Surgery Clinic at National Research Centre

Giza, Egypt

Location

Related Publications (23)

• ELsyad MA, Abdraboh AE, Aboelnagga MM, Ghali RM, Lebshtien IT. Effect of Low-Level Laser Irradiation on Stability and Marginal Bone of Narrow Implants Retaining Overdentures in Moderately Controlled Diabetic Patients. J Oral Implantol. 2019 Oct;45(5):391-397. doi: 10.1563/aaid-joi-D-18-00263. Epub 2019 Aug 7.

  PMID: 31389750 BACKGROUND

• Naujokat H, Kunzendorf B, Wiltfang J. Dental implants and diabetes mellitus-a systematic review. Int J Implant Dent. 2016 Dec;2(1):5. doi: 10.1186/s40729-016-0038-2. Epub 2016 Feb 11.

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• Taha SK, El Fattah SA, Said E, Abdel-Hamid MA, Nemat AH, El Shenawy H. Effect of Laser Bio-Stimulation on Mandibular Distraction Osteogenesis: An Experimental Study. J Oral Maxillofac Surg. 2018 Nov;76(11):2411-2421. doi: 10.1016/j.joms.2018.04.030. Epub 2018 May 7.

  PMID: 29856939 BACKGROUND

• 4. El-banna R, Shafik M, Shoreibah E: Effect of Platelet Rich Fibrin on the Healing of Intra-bony Defects: A Clinical Study. ADJ-for Girls, Vol. 5, No. 1, January (2018) - PP. 29:35 doi10.21608/adjg.2018.7990

  BACKGROUND

• 5.Ghazal, Asmaa M.; Hassan, Susan H.; Mohamed, Fatma I.; Namat, Amany H.; and Taha, Said K. (2023)

  BACKGROUND

• 6.Allam AF, Zaky AA, Elshenawy HM, Safwat EM, Hassan ML, Nassar MA, Taha, S.K: Evaluating The Biostimulation Effect Of Diode Laser 650 Nm Combined With TEMPO Oxidized Nano-Cellulose Mixed With Biphasic Tricalcium Phosphate On Bone Healing: Experimental Animal Study. Journal of pharmaceutical Negative Results ¦ Volume 14 ¦ Special Issue 2 ¦ 2023

  BACKGROUND

• Khorshidi H, Raoofi S, Bagheri R, Banihashemi H. Comparison of the Mechanical Properties of Early Leukocyte- and Platelet-Rich Fibrin versus PRGF/Endoret Membranes. Int J Dent. 2016;2016:1849207. doi: 10.1155/2016/1849207. Epub 2016 Jan 6.

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• 8-Mowla AE, Sherif H, Bashir D. Evaluation of the effect of platelet rich fibrin (PRF) on bone regeneration in the tibia of diabetic rats (histological and immunohistochemical studies). Egypt J Histol.2020; 43(3): 777-790.

  BACKGROUND

• Mayer L, Gomes FV, de Oliveira MG, de Moraes JF, Carlsson L. Peri-implant osseointegration after low-level laser therapy: micro-computed tomography and resonance frequency analysis in an animal model. Lasers Med Sci. 2016 Dec;31(9):1789-1795. doi: 10.1007/s10103-016-2051-3. Epub 2016 Aug 17.

  PMID: 27534769 BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• 11- Choukroun J AF,Schoeffler C, Vervelle A. Une opportunite en paro-implantologie:Le PRF.Implantodontie2001;42:55-62

  BACKGROUND

• Matys J, Swider K, Grzech-Lesniak K, Dominiak M, Romeo U. Photobiomodulation by a 635nm Diode Laser on Peri-Implant Bone: Primary and Secondary Stability and Bone Density Analysis-A Randomized Clinical Trial. Biomed Res Int. 2019 Apr 22;2019:2785302. doi: 10.1155/2019/2785302. eCollection 2019.

  PMID: 31143771 BACKGROUND

• Dos Santos RG, Santos GS, Alkass N, Chiesa TL, Azzini GO, da Fonseca LF, Dos Santos AF, Rodrigues BL, Mosaner T, Lana JF. The regenerative mechanisms of platelet-rich plasma: A review. Cytokine. 2021 Aug;144:155560. doi: 10.1016/j.cyto.2021.155560. Epub 2021 May 15.

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  PMID: 33768820 BACKGROUND

• 15- El-banna R, Shafik M, Shoreibah E, Zouair M,Adel Hamid M: Effect of Platelet Rich Fibrin on the Healing of Intra-bony Defects: A Clinical and Experimental Study. Dissertation, faculty of dental Medicine -Al Azhar University 2017

  BACKGROUND

• Karaca IR, Ergun G, Ozturk DN. Is Low-level laser therapy and gaseous ozone application effective on osseointegration of immediately loaded implants? Niger J Clin Pract. 2018 Jun;21(6):703-710. doi: 10.4103/njcp.njcp_82_17.

  PMID: 29888715 BACKGROUND

• Arakeeb MAA, Zaky AA, Harhash TA, Salem WS, El-Mofty M. Effect of Combined Application of Growth Factors and Diode Laser Bio-Stimulation on the Osseo Integration of Dental Implants. Open Access Maced J Med Sci. 2019 Aug 12;7(15):2520-2527. doi: 10.3889/oamjms.2019.672. eCollection 2019 Aug 15.

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• Sleem SSMEB, Zayet MK, El-Ghareeb TI, Saleh HAK. Evaluation of The Bio-Stimulatory Effect of Platelet Rich Fibrin Augmented by Diode LASER Compared to Platelet Rich Fibrin Alone on Dental Implant Replacing Posterior Mandibular Teeth. Randomised Clinical Trial: Split Mouth Study. Open Access Maced J Med Sci. 2019 Mar 14;7(5):869-875. doi: 10.3889/oamjms.2019.183. eCollection 2019 Mar 15.

  PMID: 30962853 BACKGROUND

• Soares LG, Magalhaes EB, Magalhaes CA, Ferreira CF, Marques AM, Pinheiro AL. New bone formation around implants inserted on autologous and xenografts irradiated or not with IR laser light: a histomorphometric study in rabbits. Braz Dent J. 2013;24(3):218-23. doi: 10.1590/0103-6440201302186.

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  PMID: 25975746 BACKGROUND

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  PMID: 25958474 BACKGROUND

• Kusek ER. Immediate implant placement into infected sites: bacterial studies of the Hydroacoustic effects of the YSGG laser. J Oral Implantol. 2011 Mar;37 Spec No:205-11. doi: 10.1563/AAID-JOI-D-10-00014. Epub 2010 Aug 16.

  PMID: 20712437 BACKGROUND

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  PMID: 2099210 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Noha M Ismael, PhD

  National Research Centre, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both the participants as in group 1 or control laser device is off (not active)while in group 2 laser device is active. Outcome Assessor is blinded as the cases is coded and unknown for the Assessor
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 22 implants were divided randomly into 2 groups. Group1: control group (no laser irradiation), group2: diode laser irradiation group

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: January 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

EG (1)