Different Autologous Products in The Treatment of Intrabony Defects

NCT05941312 | Completed

• 1 other identifier: 17.06.2020/19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate and compare the efficiencies of platelet-rich fibrin (PRF), concentrated growth factor (CGF) and autologous bone graft (ABG) in the treatment of patients who have intrabony pockets clinically and to assess the alveolar bone gain (AB gain) radiographically ((Panoramic X-ray and cone-beam computed tomography (CBCT) X-ray)).

Conditions

Periodontal Pocket

Keywords

Autologous bone graft; concentrated growth factor; platelet-rich fibrin

Outcome Measures

Primary Outcomes (2)

• Probing depth (PD)

  Probing depth (PD) was measured from the gingival margin to the bottom of the pocket

  Baseline (day 0) PD was evaluated. The change between baseline measurements and day 90 measurements was evaluated. Finally, the change between the baseline measurements and the 180th day measurements was evaluated.

• Alveolar bone height loss (ABHL)

  Alveolar bone height loss (ABHL) was measured using CBCT images from the distance between cementoenamel junction to the most apical base of the pocket.

  Baseline (day 0) ABHL was evaluated. The change between the baseline measurements and the 180th day measurements was evaluated.

Secondary Outcomes (4)

• Plaque index (PI)

  days 0, 30, 90 and 180

• Gingival index (GI)

  days 0, 30, 90 and 180

• Tooth mobility (TM)

  days 0, 30, 90 and 180

• Clinical attachment level (CAL)

  days 0, 90 and 180

Study Arms (4)

CONTROL GROUP (GROUP 1)

ACTIVE COMPARATOR

Only open flap debridement (OFD): Conventional OFD surgery was applied to patients in all groups which began with local anesthesia (4% articaine with 1:100 000 epinephrine) after the surgical area was disinfected. Defects were thoroughly debrided firstly by using periodontal curettes and then cleaned by piezoelectric ultrasonic scaler. For the control group, the defects were left without adding any products.

Procedure: autologous products

GROUP 2

ACTIVE COMPARATOR

Conventional OFD surgery was applied to patients in all groups which began with local anesthesia (4% articaine with 1:100 000 epinephrine) after the surgical area was disinfected. Defects were thoroughly debrided firstly by using periodontal curettes and then cleaned by piezoelectric ultrasonic scaler. After the operation area was washed thoroughly with saline, platelet-rich fibrine (PRF) was placed inside defects

Procedure: autologous products

GROUP 3

ACTIVE COMPARATOR

Conventional OFD surgery was applied to patients in all groups which began with local anesthesia (4% articaine with 1:100 000 epinephrine) after the surgical area was disinfected. Defects were thoroughly debrided firstly by using periodontal curettes and then cleaned by piezoelectric ultrasonic scaler. After the operation area was washed thoroughly with saline, Consantrated Growth Factor (CGF) was placed inside defects

Procedure: autologous products

GROUP 4

ACTIVE COMPARATOR

Conventional OFD surgery was applied to patients in all groups which began with local anesthesia (4% articaine with 1:100 000 epinephrine) after the surgical area was disinfected. Defects were thoroughly debrided firstly by using periodontal curettes and then cleaned by piezoelectric ultrasonic scaler. After the operation area was washed thoroughly with saline, autologous bone graft (ABG) was placed inside defects

Procedure: autologous products

Interventions

autologous products PROCEDURE

After the operation area was washed thoroughly with saline, autologous products were placed inside defects according to the related group. For the control group, the defects were left without adding any products.

CONTROL GROUP (GROUP 1); GROUP 2; GROUP 3; GROUP 4

Eligibility Criteria

• Age: 30 Years - 53 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• no systemic disease
• presence of two-wall intrabony defects with radiographic depth ≥3 mm
• presence of at least four intrabony defects, one in each quadrant (in molar and premolar regions)
• pocket depth ≥5mm
• no periodontal treatment within past 6 months

You may not qualify if:

• Smoking
• Having a systemic disease that may affect the treatment results such as uncontrolled diabetes, metabolic bone diseases, hematological disorders, radiotherapy in the head and neck region, kidney disease,
• Being in pregnancy or breastfeeding period,

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Ahmet Cemil TALMAC

Van, 65080, Turkey (Türkiye)

Location

Related Publications (1)

• Ghanaati S, Booms P, Orlowska A, Kubesch A, Lorenz J, Rutkowski J, Landes C, Sader R, Kirkpatrick C, Choukroun J. Advanced platelet-rich fibrin: a new concept for cell-based tissue engineering by means of inflammatory cells. J Oral Implantol. 2014 Dec;40(6):679-89. doi: 10.1563/aaid-joi-D-14-00138.

  PMID: 24945603 RESULT

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Basem ALSHUJAA, PhD

  Special dental clinic

  PRINCIPAL INVESTIGATOR

• Ahmet Cemil TALMAC, PhD

  Yuzuncu Yil University

  STUDY DIRECTOR

• Dicle ALTINDAL, PhD

  Yuzuncu Yil University

  STUDY CHAIR

• Anas ALSAFADI, PhD

  Special dental clinic

  STUDY CHAIR

• Abdullah Seckin ERTUGRUL, PhD

  Izmir Katip Celebi University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD,DDA, Assistant professor

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 12, 2023
• Study Start: August 19, 2020
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)