Wound Healing
Conditions
Brief summary
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.
Interventions
OTHERCHX 0.09% + Citrox + HA
The patient will use the assigned mouthwash starting 24 hours after the surgical procedures and continuing twice a day for 14 days.
DRUGCHX 0.12%
The patient will use the assigned mouthwash starting 24 hours after the surgical procedures and continuing twice a day for 14 days.
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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; * Ability and willingness to give written informed consent; * Written agreement to participate in the trial.
Exclusion criteria
* 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; * Conditions of the teeth or of the site that contraindicate the surgery (severe mobility, fractures, untreated endodontic lesions, incongruous restorations); * Patients with previous periodontal treatment or who were undergoing a course of dental or orthodontic treatment will be also excluded. * Tobacco use (10 or more cigarettes per day) * Inability to comply with protocol * Uncooperative patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oedema | 1, 3, 7 an 14 days | Presence of absence will be recorded (1 or 0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early Healing Score | 24 hours post surgery, 3, 7 and 45 days post surgery | The score comprises three parameters (Clinical signs of re-epithelialization, hemostasis and inflammation) and ranges from 0 (worst healing) to 10 (best healing) |
| Plaque Index modified by Turesky | 1,3,7 and 14 days post surgery | — |
| Gingival Index modified by Trombelli | 1,3,7 and 14 days post surgery | — |
| Lobene Index modified | 1,3,7 and 14 days post surgery | Presence of stains or discolorations of teeth and mucosae |
| Adverse effects | 1,3,7 and 14 days post surgery | Disgeusia, mouth ulcers |
Countries
Italy
Contacts
Primary ContactAndrea Pilloni, Professor
Outcome results
None listed