Effect of Delmopinol on treatment of Peri - implant mucositis : a randomised controlled clinical trial

Peri-implant mucositis describes an inflammatory lesion that resides in the
mucosa around osseo integrated dental implants. If left untreated, peri-implant
mucositis can progress to peri-implantitis with accompanying bone loss. Due to
the fact that peri-implant mucositis represents the obvious precursor of
peri-implantitis as does gingivitis for periodontitis, treatment of
peri-implant mucositis has to be the pre-requisite for the prevention of
peri-implantitis (Lang 2011).The current recommendation for the treatment of
peri-implant mucositis is mechanical debridement with or without antiseptics in
addition to reinforcement of self performed oral hygiene.(Heitz-Mayfield,
Needleman et al. 2013) Antibiofilm agent Delmopinol has been proven to be
effective in treatment of gingivitis and has been suggested as an alternative
for Chlorhexidine (Collaert 1992, Addy, Moran et al. 2007). However, there are
still no studies available to assess the effect of antibiofilm agent Delmopinol
on peri-implant mucositis.

The primary objective of this study is to evaluate the effect (reduction of
bleeding on probing) after mechanical debridement alone or treatment with
delmopinol or chlorhexidine mouth rinse as an adjunct to mechanical debridement
around implants with peri-implant mucositis during a period of 3 months.

The trial is designed as a randomised, double blind, placebo controlled,
parallel group intervention study of 3 months duration. Patients are randomly
allocated into one of the three treatment groups: mechanical debridement alone,
mechanical debridement with additional use of Delmopinol, mechanical
debridement with additional use of Chlorhexidine for a duration of 1 month and
the results are followed up till 3 months.

First group receives mechanical debridement together with a placebo mouth rinse
solution. The second group receives mechanical debridement together Delmopinol
Mouth rinse solution (consisting of 0.2% w/v Delmopinol Hydrochloride).The
third group receives mechanical debridement together Chlorhexidine Mouth rinse
solution (consisting of 0.2% w/v Chlorhexidine digluconate.

The burden and risks in this study are comparable to regular clinical
treatments.The appointments will be performed according to regular treatment
appointments; the extra time in this study for each subject is about 40
minutes. Risk benefit analysis: Delmopinol and Chlorhexidine used in this study
are regularly used in dental practices. The safety profile of Delmopinol and
Chlorhexidine is well established. The study will create new possibilities for
treating peri implant mucositis.