Minimally Invasive Non-Surgical Periodontal Therapy Alone vs. Minimally Invasive Non-Surgical Periodontal Therapy With I-PRF With or Without Chlorhexidine on Stage III Periodontitis Patients

NCT07791238 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: PER333
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to assess the effect of chlorhexidine augmented I-PRF together with MINST and I-PRF alone with MINST versus MINST alone in the treatment of stage III periodontitis patients.

Conditions

Bony Defects; Periodontal Disease

Keywords

Intrabony defects; periodontitis; MINST; i-PRF; CHX

Outcome Measures

Primary Outcomes (1)

• Probing depth reduction (PD)

  Will be measured from the gingival margin to the bottom of the gingival sulcus. Unit of Measurement Millimeter

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (8)

• Clinical Attachment Level (CAL)

  From enrollment to the end of treatment at 6 months

• Gingival recessions (GR)

  From enrollment to the end of treatment at 6 months

• Biochemical marker levels in GCF samples (TNF-α, IL-1β and IL-10 levels)

  From enrollment to the end of treatment at 6 months

• Patient reported outcomes

  at end of treatment at 6 months

• Perceived post-operative pain/discomfort

  at the end of treatment at 6 months

Study Arms (3)

MINST alone

ACTIVE COMPARATOR

careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed

Procedure: Minimally Invasive Nonsurgical Therapy

MINST + I-PRF alone

EXPERIMENTAL

careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient.

Procedure: Minimally Invasive Nonsurgical Therapy; Biological: Injectable Platelet-Rich Fibrin

MINST + I-PRF + CHX

EXPERIMENTAL

careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. Before the collection and centrifugation of the blood from volunteers, 200 microliter of the drug solution is dispensed at the bottom of the eppendorf vial microtube and kept ready. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient. Once I-PRF is obtained after centrifugation, 2 ml of it is added to the eppendorf vortexex

Procedure: Minimally Invasive Nonsurgical Therapy; Biological: Injectable Platelet-Rich Fibrin; Drug: Chlorhexidine 2%

Interventions

Minimally Invasive Nonsurgical Therapy PROCEDURE

careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed.

MINST + I-PRF + CHX; MINST + I-PRF alone; MINST alone

Injectable Platelet-Rich Fibrin BIOLOGICAL

careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient.

MINST + I-PRF + CHX; MINST + I-PRF alone

Chlorhexidine 2% DRUG

careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. Before the collection and centrifugation of the blood from volunteers, 200 microliter of the drug solution is dispensed at the bottom of the eppendorf vial microtube and kept ready. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient. Once I-PRF is obtained after centrifugation, 2 ml of it is added to the eppendorf vortexex

MINST + I-PRF + CHX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient-related criteria:
• Patient consulting in the outpatient clinic.
• Age ≥ 18 years old.
• Able to tolerate the study procedures.
• Patient ready to perform oral hygiene instructions.
• Compliance with the maintenance program.
• Provide informed consent.
• Accepts the 6 months follow-up period.
• Teeth related criteria:
• Presence of at least one radiographic intrabony defect depth ≥3 mm.
• Patients with at least 10 teeth per arch.
• Presence at least of two teeth with PD ≥ 6 mm per quadrant.
• Isolated inter-proximal defect on a single-rooted tooth or mandibular molar, not extending to the furcation area.
• Untreated patients diagnosed with stage III with slow/moderate rate of progression grade (A/B) Periodontitis.

You may not qualify if:

• Patient-related criteria:
• Medically compromised patients.
• Pregnant or nursing women.
• Uncooperative patients.
• Smokers (\> 10 cigarettes/day).
• Teeth related criteria:
• Furcation involvement.
• Mobility ≥ degree 1
• Acute periodontal or endodontic abscesses
• Third molars
• Non-surgical periodontal treatment in the past 6 months, or surgical periodontal treatment in the past 12 months.
• Antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy.
• Previous periodontal surgery.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• Nibali L, Koidou V, Salomone S, Hamborg T, Allaker R, Ezra R, Zou L, Tsakos G, Gkranias N, Donos N. Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial. Trials. 2019 Jul 27;20(1):461. doi: 10.1186/s13063-019-3544-8.

  PMID: 31351492 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Karim Fawzy El-sayed, Professor

  Cairo University

  STUDY CHAIR

• Weam Elbattawy, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Salma ossama Zaaya, Master Degree

CONTACT

(+20)1111101489; salma.ezzat@dentistry.cu.edu.eg

Karim fawzy El-sayed, professor

CONTACT

(+20)1005444050; karim.fawzy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator Salma Zaaya

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08