Clinical Efficacy of a Chlorhexidine-based Mouth-rinse Containing Citrus Aurantium Amara

ConditionWound Healing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Roma La Sapienza

About this trial

The primary objective of the study is the evaluation of efficacy of a mouthwash cointaining Chlorexidine (CHX) 0.09% + HA + Citrox (test group) on the quality of wound healing and the presence plaque formation and gingival inflammation in the post-surgical phase. Futhermore stains, discolorations and adverse effects will be eventually recorded. Control group will be represented by the use of a CHX 0.12% mouthwash.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

More than 20 natural teeth excluding the third molars

Clinical indication for a surgical intervention for the treatment of at least one residual pocket after non-surgical therapy (pocket depth (PD) ≥5mm)

Have a full mouth plaque score (FMPS) <15% before surgery;

Have a full mouth bleeding score (FMBS) <15% before surgery;

Disqualifiers

Use of medications, such as anti-platelet or anti-coagulant agents, any other concomitant systemic disorder, cardiovascular and diabetes diseases, allergic, infectious diseases and medications affecting periodontal inflammation

Pregnancy or breastfeeding;

Use of medication affecting the healing process;

Assumption of systemic or local antibiotics in the 4 weeks before trial beginning;

Trial design

Design model

Parallel

Treatments tested in this trial

  • CHX 0.09% + Citrox + HA

    Other intervention

    The patient will use the assigned mouthwash starting 24 hours after the surgical procedures and continuing twice a day for 14 days.

  • CHX 0.12%

    Drug

    The patient will use the assigned mouthwash starting 24 hours after the surgical procedures and continuing twice a day for 14 days.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Test groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Oedema

Presence of absence will be recorded (1 or 0).

Time frame
1, 3, 7 an 14 days

Secondary outcomes

1

Early Healing Score

The score comprises three parameters (Clinical signs of re-epithelialization, hemostasis and inflammation) and ranges from 0 (worst healing) to 10 (best healing)

Time frame
24 hours post surgery, 3, 7 and 45 days post surgery
2

Plaque Index modified by Turesky

Time frame
1,3,7 and 14 days post surgery
3

Gingival Index modified by Trombelli

Time frame
1,3,7 and 14 days post surgery
4

Lobene Index modified

Presence of stains or discolorations of teeth and mucosae

Time frame
1,3,7 and 14 days post surgery

Other outcomes

Sponsors and contacts

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