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NCT04881357: LacerINT
Antiplaque/Antigingivitis Effect of Lacer Oros Integral
NA trial testing test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain). in Periodontitis in 30 participants. Completed in 10 July 2022.
10 July 2022
Quick facts
| Lead sponsor | Universidad Complutense de Madrid |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 4 September 2021 |
| Primary completion | 10 July 2022 |
| Estimated completion | 10 July 2022 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).
- control group — full drug profile →
Conditions studied
- Periodontitis — all drugs for Periodontitis →
- Dental Plaque — all drugs for Dental Plaque →
- Gingival Inflammation — all drugs for Gingival Inflammation →
Sponsor
Universidad Complutense de Madrid — full company profile →
Who can join
Adults 35 to 64, any sex, with Periodontitis or Dental Plaque. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background; A new mouth rinse formulation ("Lacer Oros Acción Integral", Lacer SA, Barcelona, Spain) has been recently proposed, including O-Cymen-5-ol, potassium nitrate, zinc chloride, dipotassium glycyrrhizate, sodium fluoride, panthenol and xylitol, within its ingredients. Thus, it may be relevant to test the efficacy of this new "Lacer Oros Acción Integral" mouth rinse formulation in a RCT. Primary Objective: The primary objective of this RCT will be to evaluate the antiplaque/antigingivitis effects of the test mouth rinse. Population: Consecutive subjects in supportive periodontal therapy (SPT) will be screened at the Post-Graduate Periodontal Clinic in the University Complutense, Madrid, and enrolled in the clinical trial if they are periodontitis patients, already enrolled in a SPT, for at least 6 months, systemically healthy, with moderate gingival inflammation and complains of dentin hypersensitivity. Study design: pilot, parallel, double-blind, randomized, placebo-controlled, 12-week, clinical trial Intervention: The experimental group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain). The control group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the control mouth rinse (Lacer Oros Acción Integral - new formula, without active ingredients, Barcelona, Spain). Visits: Screening, baseline, 2 and 12 weeks. Outcomes: Periodontal clinical outcomes (plaque levels, gingival condition, probing pocket depth), Stainign, Microbiological outcomes (culture and qPCR). Patient reported outcomes, compliance, adverse effects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04881357
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04881357 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad Complutense de Madrid
- Last refreshed: 25 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04881357.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing