Periodontal Pocket Clinical Trial
Official title:
Investigation of the Safety and Efficacy of a Periodontal In-situ Gelling Product, Pocket-X Gel, in the Treatment of Periodontal Pockets Following Scaling and Root Planing
This study is an open-label split-mouth study in which Pocket-X Gel, a periodontal in-situ gelling product, will be applied to periodontal pockets in one/two mouth segment(s) of participants, following scaling and root planing on the entire mouth, while the contralateral segment(s) will serve as control. The aim of the study is to investigate the safety and efficacy of Pocket-X Gel in improving the healing of the gingiva and preventing bacterial re-colonization in the periodontal pocket following scaling and root planing.
This study is an open-label split-mouth study that investigates the safety and efficacy of
Pocket-X Gel, a periodontal in-situ gelling product, in improving the healing of the gingiva
and preventing bacterial re-colonization in the periodontal pocket following scaling and root
planing.
The study includes a single arm. All participants will undergo 1-4 sessions of scaling and
root planing (SRP), which is the conventional gold-standard treatment for periodontal
disease. The number of SRP sessions is dependent on the severity of the periodontal disease.
Following completion of SRP, participants will undergo treatment with Pocket-X Gel, which
will be inserted into periodontal pockets present in one/two of the participants mouth
segments (quadrants), following scaling and root planing. The other mouth segments will not
undergo further intervention. The number of segments to be treated is dependent on the
clinical symmetry between the treated segment(s) and the contralateral segment(s).
Participants will be followed for a total duration of 6 months. Additional application of
Pocket-X Gel may occur 1 month and/or 3 months following first application, depending on the
state of the participant's periodontal disease.
The rationale for the study is the hypothesis that a physical barrier inserted into
periodontal pockets following scaling and root planing would assist in maintaining the pocket
clean by preventing bacteria from re-entering the cleaned pocket, thus allowing the gums to
properly heal and seal the pockets while preventing further inflammation.
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