NCT07538661

Brief Summary

This observational study documents the clinical outcomes of a proprietary, safe-to-swallow metabolic protocol for chronic gum disease. Based on 21 years of research and a focused 20-patient cohort, the study records visible clinical improvements in gingival inflammation and tissue color within 7 to 14 days. The protocol focuses on restoring the metabolic environment to achieve non-surgical periodontal pocket stabilization and natural tissue re-attachment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 13, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

Gingival RegenerationMetabolic RepairNon-Surgical Periodontal Treatment

Outcome Measures

Primary Outcomes (1)

  • Visible reduction in gingival inflammation and erythema (redness) observed within 7 to 14 days

    7 to 14 days

Secondary Outcomes (1)

  • Measurement of periodontal pocket depth reduction and tissue stability at 6 weeks

    6 weeks

Interventions

Topical application of a proprietary, 100% food-grade (GRAS) nutraceutical formulation specifically designed for rapid gingival tissue regeneration and inflammation reversal. Key Performance Indicators: Speed: Clinical onset of action visible within 3 days. Safety: Completely safe for ingestion (edible), eliminating common side effects of chemical antiseptics like staining or taste alteration. Efficacy: Significant reduction in redness and bleeding (BOP) within 7 to 14 days, as demonstrated in our cohort of 20+ subjects. Mechanism: Supports the natural healing of the gum 'peau' (epithelium) through host-response modulation rather than harsh disinfection.

Topical application of a proprietary, 100% food-grade (GRAS) nutraceutical formulation specifically designed for rapid gingival tissue regeneration and inflammation reversal.Key Performance Indicators: Speed: Clinical onset of action visible within 3 days. Safety: Completely safe for ingestion (edible), eliminating common side effects of chemical antiseptics like staining or taste alteration. Efficacy: Significant reduction in redness and bleeding (BOP) within 7 to 14 days, as demonstrated in our cohort of 20+ subjects. Mechanism: Supports the natural healing of the gum 'peau' (epithelium) through host-response modulation rather than harsh disinfection."

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18 to 75 years diagnosed with chronic periodontitis, characterized by gingival inflammation, bleeding on probing, and periodontal pocket depths of 4mm or greater. The population includes individuals seeking non-surgical alternatives for gum tissue recovery.

You may qualify if:

  • Patients (18-75) with documented chronic periodontitis and pocket depths \>4mm.

You may not qualify if:

  • Active oral malignancy or pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zireg

Bordj Bou Arreridj, Wilaya de Bordj Bou Arréridj, 34000, Algeria

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
sponsor investigator

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

January 3, 2026

Primary Completion

February 20, 2026

Study Completion

February 26, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations