Local Minocycline in Patients Under Supportive Periodontal Therapy
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aims of the present study are to assess the significance of the adjunctive effect of the
      subgingival application of a 2% minocycline hydrochloride controlled-delivery system (MHS) in
      comparison to subgingival instrumentation with application of a placebo gel, 3 months after
      therapy in subjects with recurrent periodontitis undergoing supportive periodontal therapy
      (SPT) and to assess the substantivity of the gel attributable to the adjunctive delivery of
      the medication that is detected at 3 months during a 9-month period of regular SPT. Recurrent
      periodontitis will be defined as sites with residual periodontal probing depths and bleeding
      on probing after completion of initial periodontal therapy. This will include both persistent
      and recurrent periodontitis, where persistent means the residual periodontal site after
      initial periodontal therapy, and recurrent means the site which was improved by initial
      periodontal therapy, but disease recurred.
    

Detailed description: 
      It has been reported that regular maintenance of subjects with treated periodontal disease is
      the key consideration in the long-term periodontal prognosis of these subjects. Periodic
      prophylaxis may prevent loss of clinical attachment over long periods of time even in
      patients with less than optimal plaque control. However, there are limitations in routine
      subgingival re-instrumentation especially in bleeding pockets, as only 50% of these sites
      improve. Furthermore, the persistence of bleeding pockets increases the risk of disease
      progression and tooth loss. Thus there is a need for adjuncts that may improve the outcome
      especially in subjects with recurrent periodontitis during SPT. Some studies reported
      significantly better results with subgingival administration of local minocycline in residual
      pockets post initial periodontal therapy over a short period of time. There are few studies
      assessing the efficacy of topical minocycline gel in subjects with recurrent periodontitis
      while in SPT, and the long term effect.

      The present study will examine the significance of the adjunctive effect of the subgingival
      application of a 2% minocycline hydrochloride controlled-delivery system (MHS) in comparison
      to subgingival instrumentation with application of a placebo gel, 3 months after therapy in
      subjects with recurrent periodontitis undergoing supportive periodontal therapy (SPT) and to
      assess the substantivity of the gel attributable to the adjunctive delivery of the medication
      that will be detected at 3 months during a 9-month period of regular SPT.
    

Intervention name(s): 2% minocycline hydrochloride controlled-delivery system (MHS); Placebos
Intervention type(s): Drug; Drug
Intervention description(s): The test product is a highly viscous gel for local subgingival placement composing of an ointment containing micro-capsule type particles for sustained release and the active ingredient 2% minocycline gel (10mg in each syringe of 0.5g) (Periocline, SUNSTAR, Osaka, Japan). The other ingredients include magnesium chloride, hydroxyl-ethylcellulose, aminoalkylmethacrylaye copolymer, triacetin and concentrated glycerine, giving the preparation a sustained-released property. It will be applied to experimental teeth and the adjacent teeth by gently inserting the tip of a specially designed applicator until the paste flows over the gingival margin.; It is the same gel as MHS but without active ingredient minocycline hydrochloride.
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, double blinded trial in parallel group
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Recurrent periodontitis; Periodontal therapy