NCT06625528

Brief Summary

The present study will be performed to evaluate the efficacy of lyophilized platelet-rich fibrin alone and combined with nanocrystalline hydroxyapatite in treatment of periodontal intra-bony defects through:

  • The clinical parameters including: Probing pocket depth (PPD) reduction and clinical attachment level (CAL) gain.
  • The radiographic parameters including: Marginal bone level (MBL), bone-defect fill.
  • Secondary outcome: The level of BMP-2 in Gingival crevicular fluid (GCF).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.4 years

First QC Date

September 26, 2024

Last Update Submit

October 10, 2024

Conditions

Treatment of Periodontal Intra-bony Defects

Keywords

periodontitislyophilized-PRFPeriodontal intra-Bony DefectsPeriodontal angular bone defect

Outcome Measures

Primary Outcomes (2)

  • radiographic parameters

    The radiographic parameters including: Bone-defect fill in mm.

    baseline, 3, 6, and 9 months after treatment

  • clinical parameters

    The clinical parameters including: Clinical attachment level (CAL) gain in mm.

    baseline, 3, 6, and 9 months after treatment.

Secondary Outcomes (1)

  • biochemical evaluation

    baseline, 1, 4 and 12 weeks after surgery

Study Arms (3)

open flap debridement

PLACEBO COMPARATOR

Immediately before surgery, patients rinsed with 0.12% chlorhexidine digluconate and povidone iodine solution was used to perform extra-oral antisepsis. The surgical site was anaesthetized. A mucoperiosteal flap was elevated and reflected followed by thorough debridement of all inflammatory granulation tissue from IBD until a sound, healthy bone surface was obtained. Root surface debridement was also performed. Copious irrigation with normal saline solution. The flap was repositioned and sutured.

Biological: open flap debridement

lyophilized platelet rich fibrin

ACTIVE COMPARATOR

Immediately before surgery, patients rinsed with 0.12% chlorhexidine digluconate and povidone iodine solution was used to perform extra-oral antisepsis. The surgical site was anaesthetized. A mucoperiosteal flap was elevated and reflected followed by thorough debridement of all inflammatory granulation tissue from IBD until a sound, healthy bone surface was obtained. Root surface debridement was also performed. Copious irrigation with normal saline solution. The lyophilized-PRF granules was hydrated with a few drops of normal saline then, it was applied and packed to fill defect. The flap was repositioned and sutured.

Biological: open flap debridement

lyo-PRF and nanocrystalline hydroxyapatite bone graft

ACTIVE COMPARATOR

Immediately before surgery, patients rinsed with 0.12% chlorhexidine digluconate and povidone iodine solution was used to perform extra-oral antisepsis. The surgical site was anaesthetized. A mucoperiosteal flap was elevated and reflected followed by thorough debridement of all inflammatory granulation tissue from IBD until a sound, healthy bone surface was obtained. Root surface debridement was also performed. Copious irrigation with normal saline solution. A mixture of Ly-PRF and n-HA (1:1by weight) was hydrated with a few drops of normal saline then, it was applied and packed to fill the defect. The flap was repositioned and sutured.

Biological: open flap debridement

Interventions

open flap debridementBIOLOGICAL

does lyophilized platelet rich fibrin combined with open flap debridement or combination of open flap debridement, lyophilized platelet rich fibrin and nano-crystalline hydroxyapatite bone substitute can add benefits to open flap debridement alone or not

Also known as: lyophilized platelet rich fibrin combined with open flap debridement, combination of lyophilized platelet rich fibrin and nano-crystalline hydroxyapatite bone substitute
lyo-PRF and nanocrystalline hydroxyapatite bone graftlyophilized platelet rich fibrinopen flap debridement

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm.
  • or 3-wall intra-bony interproximal defect with depth ≥3 mm, a width of ≥3 mm at its most coronal part and 45-55-degree angulation will be selected in order to reduce defect variability.
  • All patients will be free from any systemic diseases according to the American Dental Academy general guidelines for referring dental patients to specialists and other care settings

You may not qualify if:

  • Any patients with any systemic condition that contraindicate any surgical intervention.
  • Pregnant or lactating females, smokers, or alcoholic patients.
  • Patients with intra-bony defects received drugs that affect bone turnover such as (chemotherapy and radiotherapy).
  • History of periodontal therapy and antibiotic administration in the last 6 months.
  • Patients taking any medicine which may affect the function of platelet (i.e., aspirin) in the previous 3 months.
  • Miller grade II or greater mobility, furcation involvement as well as one-wall defects and interdental craters.
  • Patients with unacceptable oral hygiene after the re-evaluation of phase I therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine, Al- Azhar University,

Asyut, Egypt

Location

Related Publications (9)

  • Anoixiadou S, Parashis A, Vouros I. Minimally Invasive Non-Surgical Technique in the Treatment of Intrabony Defects-A Narrative Review. Dent J (Basel). 2023 Jan 11;11(1):25. doi: 10.3390/dj11010025.

    PMID: 36661562BACKGROUND

  • Tavelli L, Chen CJ, Barootchi S, Kim DM. Efficacy of biologics for the treatment of periodontal infrabony defects: An American Academy of Periodontology best evidence systematic review and network meta-analysis. J Periodontol. 2022 Dec;93(12):1803-1826. doi: 10.1002/JPER.22-0120. Epub 2022 Oct 24.

    PMID: 36279121BACKGROUND

  • Zhao R, Yang R, Cooper PR, Khurshid Z, Shavandi A, Ratnayake J. Bone Grafts and Substitutes in Dentistry: A Review of Current Trends and Developments. Molecules. 2021 May 18;26(10):3007. doi: 10.3390/molecules26103007.

    PMID: 34070157BACKGROUND

  • Shaikh MS, Zafar MS, Alnazzawi A, Javed F. Nanocrystalline hydroxyapatite in regeneration of periodontal intrabony defects: A systematic review and meta-analysis. Ann Anat. 2022 Feb;240:151877. doi: 10.1016/j.aanat.2021.151877. Epub 2021 Dec 2.

    PMID: 34864225BACKGROUND

  • Liu X, Yin M, Li Y, Wang J, Da J, Liu Z, Zhang K, Liu L, Zhang W, Wang P, Jin H, Zhang B. Genipin modified lyophilized platelet-rich fibrin scaffold for sustained release of growth factors to promote bone regeneration. Front Physiol. 2022 Sep 30;13:1007692. doi: 10.3389/fphys.2022.1007692. eCollection 2022.

    PMID: 36246111BACKGROUND

  • Wang Z, Han L, Sun T, Wang W, Li X, Wu B. Preparation and effect of lyophilized platelet-rich fibrin on the osteogenic potential of bone marrow mesenchymal stem cells in vitro and in vivo. Heliyon. 2019 Nov 1;5(10):e02739. doi: 10.1016/j.heliyon.2019.e02739. eCollection 2019 Oct.

    PMID: 31720476BACKGROUND

  • Ngah NA, Dias GJ, Tong DC, Mohd Noor SNF, Ratnayake J, Cooper PR, Hussaini HM. Lyophilised Platelet-Rich Fibrin: Physical and Biological Characterisation. Molecules. 2021 Nov 25;26(23):7131. doi: 10.3390/molecules26237131.

    PMID: 34885714BACKGROUND

  • Zhu L, Liu Y, Wang A, Zhu Z, Li Y, Zhu C, Che Z, Liu T, Liu H, Huang L. Application of BMP in Bone Tissue Engineering. Front Bioeng Biotechnol. 2022 Mar 31;10:810880. doi: 10.3389/fbioe.2022.810880. eCollection 2022.

    PMID: 35433652BACKGROUND

  • Tsoromokos N, Parinussa S, Claessen F, Moin DA, Loos BG. Estimation of Alveolar Bone Loss in Periodontitis Using Machine Learning. Int Dent J. 2022 Oct;72(5):621-627. doi: 10.1016/j.identj.2022.02.009. Epub 2022 May 13.

    PMID: 35570013RESULT

Related Links

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistician and the evaluator were blinded, but the operator was not because of the nature of the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients selected in this study will be randomly divided into 3 groups: Group I: Periodontitis patients with an intra-bony defect will be treated by open flap debridement. Group II: Periodontitis patients with an intra-bony defect will be treated by open flap debridement combined with the application of lyophilized platelet-rich fibrin. Group III: Periodontitis patients with an intra-bony defect will be treated by open flap debridement and lyophilized platelet-rich fibrin combined with nanocrystalline hydroxyapatite bone substitute. All patients will be evaluated clinically, radiographically and biochemically
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 3, 2024

Study Start

November 19, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations

EG(1)