Impact of Guided Biofilm Therapy on Epithelial and Mesenc... | NCT07286916

Studies
Impact of Guided Biofilm Therapy on Epithelial and Mesenchymal Biomarkers in Periodontitis Patients

NCT07286916

Sponsor

University of Baghdad

Status

Recruiting

Last Update Posted

Feb 27, 2026Actual

Enrollment

18Estimated

Phase

Not Applicable

Conditions

Periodontitis

Interventions

Root surface debridement
Guided Biofilm Therapy

Countries

Iraq

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 4, 2026Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Dec 1, 2025

First Submission Date that Met QC Criteria

Dec 13, 2025

First Posted Date

Dec 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2026

Last Update Posted Date

Feb 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to investigate the clinical and biochemical effects of the guided biofilm therapy protocol as an alternative to the conventional non-surgical periodontal therapy in patients with periodontitis. The main question it aims to answer is:

Does the guided biofilm therapy (GBT) protocol have an impact on gingival crevicular fluid (GCF) epithelial and mesenchymal biomarkers in patients with periodontitis?

All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of toothpaste and toothbrush, with suitable interdental aids. All patients will be instructed to attend again after 7 days.

At baseline, full-mouth periodontal charting and radiographs will be obtained and after 1-hour, GCF samples will be collected from both test and control groups. Sites allocated to control group will undergo supragingival debridement by using ultrasonic device. After one week, the control group will receive RSD using area specific (Gracey) curettes (Medesy, Italy) according to the 24-hours protocol and will receive teeth polishing by using rubber polishing cups and tooth polishing paste, while the test group will receive a full GBT protocol which includes eight steps: (1) ASSESS, (2) DISCLOSE, (3) MOTIVATE, (4) AIRFLOW, (5) PERIOFLOW, (6) PIEZON PS*, (7) CHECK, and (8) RECALL. After finishing the treatment session, the patients will be asked to attend for follow up, clinical evaluation of PI, BOP, PPD, and CAL, and GCF samples collection after 1 month and 3 months.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional non-surgical periodontal therapy (NSPT)	Active Comparator	Control group	Procedure: Root surface debridement
Guided Biofilm Therapy (GBT)	Experimental	Test group	Device: Guided Biofilm Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Root surface debridement	Procedure	Control group sites that will receive conventional NSPT will undergo supragingival debridement by using ultrasonic device at baseline. After one week, sites will receive root surface debridement (RSD) using area specific (Gracey) curettes (Medesy, Italy) according to the 24-hours protocol.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in probing pocket depth (PPD)	After treatment completion PPD ≤4mm with no BOP at 4mm pockets	3 months

Secondary Outcomes

Measure	Description	Time Frame
Clinical attachment level (CAL)		3 months
Bleeding on probing (BOP)		3 months
Plaque index (PI)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult subjects (>18 years).
Subjects are not currently under active periodontal therapy or joining other trial in the last 3 months.
Patients must be diagnosed with generalized unstable periodontitis with bilateral, symmetrical distribution of PPD ≥ 4mm and positive BOP.

-

Exclusion Criteria:

Patients not diagnosed with periodontitis.
Patients consuming antibiotics.
Regular users of nonsteroidal anti-inflammatory drugs (NSAIDs).
Patients receiving periodontal treatment 3-months prior to the study.
Pregnant or mothers in a breastfeeding period.
Third molars and teeth with furcation involvement.
Patients taking antioxidant supplements.
Patients with heavy calculus that would prevent PerioPaper strips entrance to the periodontal pocket.
Patient with pulmonary diseases and with a history of allergy to erythritol.
Patients not willing to participate. -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ibrahim Haider Sadeq, B.D.S	Contact	009647722247642		Ibrahim.Ata2405@codental.uobaghdad.edu.iq

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
College of Dentistry, University of Baghdad	Recruiting	Baghdad		10047	Iraq

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D010518	Periodontitis

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Intervention Model Description

The study is a 2 arm, split-mouth, double blinded, randomized clinical trial. The first group is control group will receive conventional NSPT (scaling & root surface debridement (RSD)), while the second group is the test group will be treated according to the GBT protocol.