NCT07722390

Brief Summary

The purpose of this study is to evaluate change in pocket depth following using minimally invasive non surgical combined with injectable platelet concentrate .

Trial Health

77
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress40%
May 2025Jun 2028

Study Start

First participant enrolled

May 14, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

2.6 years

First QC Date

July 20, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

intrabony defect - MINST - IPR-F

Outcome Measures

Primary Outcomes (1)

  • Change in pocket depth

    Baseline measurements will be taken at the first visit. Probing depth will be measured at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) using a UNC-15 periodontal probe

    6 months

Secondary Outcomes (4)

  • Pocket closure

    6 months from baseline

  • Clinical attachment gain

    6 months from baseline

  • Radiographic defect reduction:

    6 months

  • Patient reported outcomes

    6 months

Study Arms (2)

Intervention , MINST + IPRF

EXPERIMENTAL

Participants will receive minimally invasive non-surgical periodontal therapy (MINST) with adjunctive local application of injectable platelet-rich fibrin (I-PRF) into the selected periodontal intrabony defect. I-PRF will be prepared from 10 mL of autologous venous blood and injected into the cleaned defect, followed by placement of a custom-made transparent vacuum-formed stent for 15 minutes to prolong local contact. Participants will receive standard oral hygiene instructions and periodontal follow-up.

Biological: Injectable PRF

Control , MINST only

ACTIVE COMPARATOR

Participants will receive minimally invasive non-surgical periodontal therapy (MINST) alone for the selected periodontal intrabony defect, without adjunctive I-PRF or other biomaterials. Participants will receive standard oral hygiene instructions and periodontal follow-up.

Procedure: MINST

Interventions

Injectable PRFBIOLOGICAL

I-PRF will be prepared from 10 mL of autologous venous blood and injected into the cleaned defect, followed by placement of a custom-made transparent vacuum-formed stent for 15 minutes to prolong local contact

Intervention , MINST + IPRF
MINSTPROCEDURE

Participants will receive minimally invasive non-surgical periodontal therapy (MINST) alone using P3 Woodpecker piezoelectric scaler for the selected periodontal intrabony defect

Control , MINST only

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with periodontitis stage III-IV.
  • Presence of at least one intrabony defect with radiographic component ≥ 3mm deep and PPD≥ 6mm (not affecting a tooth with 'hopeless' prognosis).
  • Patients willing to sign informed consent and to be in the study until the 6-months follow-up.
  • Full-mouth plaque score \<30% following step 1 periodontal therapy

You may not qualify if:

  • Smoker/vaper (currently or in past 5 years).
  • Contributory medical history (e.g. cardiovascular disease, diabetes, psychiatric conditions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Related Publications (5)

  • 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: 31351492BACKGROUND
  • Nibali L. Intrabony defects and non-surgical treatment. Prim Dent J. 2014 Aug;3(3):48-50. doi: 10.1308/205016814812736682.

    PMID: 25198639BACKGROUND
  • Mehta J, Montevecchi M, Garcia-Sanchez R, Onabolu O, Linares A, Eriksson F, Ghezzi C, Donghi C, Lu EM, Nibali L. Minimally invasive non-surgical periodontal therapy of intrabony defects: A prospective multi-centre cohort study. J Clin Periodontol. 2024 Jul;51(7):905-914. doi: 10.1111/jcpe.13984. Epub 2024 May 6.

    PMID: 38710583BACKGROUND
  • Iorio-Siciliano V, Blasi A, Mauriello L, Salvi GE, Ramaglia L, Sculean A. Non-Surgical Treatment of Moderate Periodontal Intrabony Defects With Adjunctive Cross-Linked Hyaluronic Acid: A Single-Blinded Randomized Controlled Clinical Trial. J Clin Periodontol. 2025 Feb;52(2):310-322. doi: 10.1111/jcpe.14078. Epub 2024 Oct 14.

    PMID: 39402910BACKGROUND
  • Alshoiby MM, Fawzy El-Sayed KM, Elbattawy W, Hosny MM. Injectable platelet-rich fibrin with demineralized freeze-dried bone allograft compared to demineralized freeze-dried bone allograft in intrabony defects of patients with stage-III periodontitis: a randomized controlled clinical trial. Clin Oral Investig. 2023 Jul;27(7):3457-3467. doi: 10.1007/s00784-023-04954-y. Epub 2023 Mar 31.

    PMID: 37002441BACKGROUND

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Biostatistician
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master degree candidate

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start

May 14, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

July 29, 2026

Record last verified: 2026-07

Locations