Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis

NCT00529555 — Phase 3, Completed, 602 participants, Sunstar Americas
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A 9 Month,3-arm Multicenter Clinical Trial of Treatment With Periocline Gel (2.1% Minocycline HCl) for Adjunctive Use to Scaling and Root Planing (SRP) in Adults With Periodontal Disease.

RegistryNCT00529555
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment602 (Actual)
SponsorSunstar Americas (Industry)
ConditionsAdult Periodontitis
Interventionsminocycline HCl 2.1%, Scaling and root planing (Drug, procedure)
Datesstart 2006-01-01, primary completion 2008-12-01, completion 2008-12-01, first posted 2007-09-14, last updated 2014-05-09
Locations10 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Adult Periodontitis All trials of minocycline HCl 2.1% All trials of Scaling and root planing

-Summary

Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of the root surfaces of the teeth. This is also called scaling and root planing. Placing a topical antibiotic into the periodontal pocket at the time of scaling and root planing may help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl) 2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now being tested in the US.

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+Arms and interventions

ArmTypeInterventionsDescription
Scaling and root planing + SHAM TXSham comparatorProcedure: Scaling and root planingsham treatment
Scaling and root planing + VehiclePlacebo comparatorProcedure: Scaling and root planingPlacebo
Scaling & root planing + Periocline GelActive comparatorDrug: minocycline HCl 2.1%Minocycline HCL 2.1%
  • minocycline HCl 2.1% (Drug), also known as periocline: Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.
  • Scaling and root planing (Procedure), also known as SRP: scaling and root planing

+Outcome measures

Primary outcomes

  • Change in Pocket Depth. [baseline & 9 months]: Average change of Pocket Depth at 9 months from baseline

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* moderate to severe periodontitis

Exclusion Criteria:

* recent periodontal therapy
* certain medical or dental conditions
* pregnancy
* allergy to active drug or related drugs

+Posted results

Participant flow

MilestoneScaling and Root Planing + SHAM TXScaling & Root Planing + Periocline GelScaling and Root Planing + Vehicle
Started200202200
Completed171172174
Not completed293026

Outcome results

  • Change in Pocket Depth. (Primary), Least squares mean, mm: Scaling and Root Planing + SHAM TX -1.4 (-1.7 to -1.1); Scaling and Root Planing + Periocline Gel -1.6 (-1.8 to -1.3); Scaling and Root Planing + Vehicle -1.4 (-1.7 to -1.1)

Adverse events

ArmDeathsSerious adverse eventsOther adverse events
Scaling and Root Planing + SHAM TX08/200 (4.0%)173/200 (86.5%)
Scaling & Root Planing + Periocline Gel05/202 (2.5%)189/202 (93.6%)
Scaling and Root Planing + Vehicle03/200 (1.5%)182/200 (91.0%)

Serious adverse events by term

TermOrgan systemScaling and Root Planing + SHAM TXScaling & Root Planing + Periocline GelScaling and Root Planing + Vehicle
Rib FractureInjury, poisoning and procedural complications1/2000/2020/200
Abdominal herniaGastrointestinal disorders1/2000/2020/200
Tooth injuryInjury, poisoning and procedural complications1/2000/2020/200
CystNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2000/2020/200
DeathSocial circumstances0/2001/2020/200
Brain neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2000/2021/200
Cellulitis and pulmonary embolismCardiac disorders1/2000/2020/200
HysterectomyReproductive system and breast disorders0/2000/2021/200
Myocardial infarction and fatigueCardiac disorders1/2000/2020/200
Right knee replacement surgeryMusculoskeletal and connective tissue disorders0/2001/2020/200
Transient ischemic attackCardiac disorders0/2001/2020/200
Chest painSocial circumstances0/2001/2020/200
Cellulitis of male organ external epididymitisReproductive system and breast disorders1/2000/2020/200
Hopsitalization for complications from Multiple SclerosisMusculoskeletal and connective tissue disorders0/2000/2021/200
Pain and injurySurgical and medical procedures1/2000/2020/200
CastSocial circumstances0/2001/2020/200

Other adverse events by term

TermOrgan systemScaling and Root Planing + SHAM TXScaling & Root Planing + Periocline GelScaling and Root Planing + Vehicle
Gastrointestinal disordersGastrointestinal disorders138/200140/202134/200
Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications71/200137/202138/200
Gerenal Disorders and adminstration site conditionsGeneral disorders30/200131/202109/200
Infections and infestationsInfections and infestations44/20041/20240/200
Nervous system disordersNervous system disorders16/20011/20216/200
Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders12/20016/20211/200
Respiratory, thoracic, and mediastinal disordersRespiratory, thoracic and mediastinal disorders27/20019/20225/200

+Locations (10)

FacilityCityCountryStatus
University of Alabama at BirminghamBirmingham, AlabamaUnited States
University of California - San FranciscoSan Francisco, CaliforniaUnited States
University of FloridaGainsville, FloridaUnited States
University of Maryland - Dental SchoolBaltimore, MarylandUnited States
Boston University Dental SchoolBoston, MassachusettsUnited States
University of Michigan Oral Health Research CenterAnn Arbor, MichiganUnited States
University of MinnesotaMinneapolis, MinnesotaUnited States
State University of New York at Buffalo, Dental MedicineBuffalo, New YorkUnited States
University of Pennsylvania Dental SchoolPhiladelphia, PennsylvaniaUnited States
University of Texas Health Science Center at San AntonioSan Antonio, TexasUnited States

+Investigators