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DiabetesPRFNCT06444334

Laser Biostimulation on Implant Covered With PRF in Controlled Diabetics

A study testing low level Diode Laser and PRF platelet rich fibrin in people with Diabetes and Implant Site Reaction, run by National Research Centre, Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 60 years
What is being tested?
low level Diode Laser and PRF platelet rich fibrin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteEgypt
Study dates
1 Jan 2023to 30 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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,
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Oral Surgery Clinic at National Research Centre

    Giza

Other trials in Egypt

About this study

Official title: Evaluation of the Effect of Laser Biostimulation on Implant Covered With PRF in Controlled Diabetic Patients: A Randomized Clinical Trial

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.

Read the 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.

Being tested
low level Diode Laser, PRF platelet rich fibrin
Keywords
laser biostimulation, PRF, implants, osseointegration, diabetic patient
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low level Diode LaserRadiation

    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

  • PRF platelet rich fibrinProcedure or surgery

    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

Study groups in NCT06444334
Study groupRoleWhat they receive
control PRF groupActive comparatorcontrolled diabetic patients with 11 implants covered with PRF inserted in posterior maxilla or mandible, not laser irradiated
Receives: Procedure: PRF platelet rich fibrin
laser and PRF test groupExperimentalcontrolled diabetic patients with 11 implants covered with PRF inserted in posterior maxilla or mandible, expoed to Diode laser irradiation
Receives: Radiation: low level Diode Laser; Procedure: PRF platelet rich fibrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (1)

  1. Implant stability measurements

    AnyCheck device (AnyCheck, Neobiotech Co., Ltd. E-space #1001, 36, Digital-ro 27-gil, Guro-gu, Seoul, Korea, 08381) was utilized 5 months (2nd stability) post implant insertion. AnyCheck is an implant stability meter that measures the stiffness of the alveolar bone-implant interface through a tapping-motion. The degree of osseointegration is calculated in terms of IST (Initial Stability Test) value between 30 to 85. AnyCheck was turned on, then, the tip of the tap¬ping rod maintained contact angle between 0 to 30 degrees with healing abutment. The START button was gently pressed while holding the device stable, the measured value displayed on the LCD screen was recorded. The smaller the measured value, the weaker the degree of osseointegration. Mesiodistal and buccolingual sides of the implant were measured, five IST readings for each side were repetitively recorded by blind examiner and the mean reading was calculated and tabulated

    Measured: only after 5 months from implant insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2024
  2. Study start1 Jan 2023
  3. Primary completion30 Mar 2024
  4. Study completion30 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
22 implants were divided randomly into 2 groups. Group1: control group (no laser irradiation), group2: diode laser irradiation group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06444334
Sponsor's protocol ID
03430423
Acronym
PRF
Status last verified
Jun 2024
First submitted
30 May 2024
Last updated
11 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31389750

  • 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.

    PubMed 27747697

  • 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.

    PubMed 29856939

  • 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

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

  • 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

  • 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.

    PubMed 26880919

  • 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.

  • 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.

    PubMed 27534769

  • 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.

    PubMed 17695343

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

  • 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.

    PubMed 31143771

  • 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.

    PubMed 34004552

  • Habash G, Jayash SN. Diode laser assisted horizontal bone defect regeneration in the treatment of peri-implantitis. Clin Case Rep. 2021 Jan 3;9(3):1247-1252. doi: 10.1002/ccr3.3741. eCollection 2021 Mar.

    PubMed 33768820

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing low level Diode Laser and PRF platelet rich fibrin in people with Diabetes and Implant Site Reaction, run by National Research Centre, Egypt at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Per-implant bone density measurements (time frame: at immediate day of surgery(baseline) and after 5 months for the same patients). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06444334, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.

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