Status:
COMPLETED
Periodontal Wound Healing With CHX and Hyaluronic Acid
Lead Sponsor:
University Hospital of Ferrara
Conditions:
Surgical Flaps
Wound Healing
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Backround: No data on the adjunctive effects of hyaluronic acid (HA) in a post-surgery, chlorhexidine (CHX) - based plaque control regimen are available. Also, contrasting evidence is available regard...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Patients were included in the study if positive for each of the following patient related criteria:
- 18 years or older;
- able and willing to provide a written informed consent;
- willing to grant the sufficient compliance with the experimental procedures.
- Patients were included in the study if positive for each of the following surgery-related criteria (verified as part of their overall treatment plan):
- indication to at least one session of oral surgery (including periodontal surgery, endodontic surgery, tooth extraction, and implant surgery) requiring the elevation of an envelope or triangular, full-thickness gingival/mucosal flap;
- indication to flap extension to the interdental papilla between either the canine and first premolar or first and second premolar to enhance surgical visibility (teeth in this area were identified as the experimental teeth);
- intact (i.e., no clinical attachment loss) or reduced periodontium with probing pocket depths ≤ 3 mm and no diastema at experimental teeth;
- indication to the repositioning of the surgical flap at the pre-surgical level on the experimental teeth at suturing (i.e. no coronal advancement or apical displacement of the flap).
- EXCLUSION CRITERIA
- Patients were excluded from the study (at either recruitment or during the experimental phase) if positive for one or more of the following patient-related criteria:
- pregnancy or lactation;
- genetic defects (e.g. Down's syndrome) with an established impact on periodontal status;
- diabetes mellitus;
- immune system disorders (e.g. HIV/AIDS);
- heavy smokers (≥ 10 cigarettes/day);
- severe blood disorders, with a documented qualitative and/or quantitative deficit of polymorphonuclears and/or platelets;
- assumption of medications affecting the gingiva and/or the oral mucosa (e.g. diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/immunomodulators),
- assumption of oral contraceptives;
- use of systemic or local antibiotics in the previous 4 weeks before study initiation and throughout the entire experimental phase;
- documented allergy to CHX and/or HA.
- Patients were excluded from the study if the experimental teeth were positive for one or more of the following criteria:
- dental treatment within the last two months;
- presence of untreated caries or endodontic lesions;
- presence of root fractures;
- tooth alterations (i.e. amelogenesis imperfecta, tetracycline staining) impairing staining evaluations;
- presence of inadequate restorations;
- orthodontic appliances;
- indication to mucogingival surgery.
Exclusion
Key Trial Info
Start Date :
December 16 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2017
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03465670
Start Date
December 16 2015
End Date
June 14 2017
Last Update
March 14 2018
Active Locations (1)
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1
University-Hospital
Ferrara, Italy