Status:
NOT_YET_RECRUITING
Efficacy of a Gel Containing Polynucleotides and Hyaluronic Acid in Supraosseous Periodontal Defects Treated with the Single Flap Approach
Lead Sponsor:
Azienda Unità Sanitaria Locale (A.U.S.L.) Ferrara, Italy
Conditions:
Periodontitis
Gingival Recession, Localized
Eligibility:
All Genders
Phase:
NA
Brief Summary
Treatment of supraosseous defects (SD) may be challenging due to their limited regenerative potential. When located in aesthetic areas, treatment may result in a gingival recession increase with conse...
Detailed Description
SDs have been indicated as the most challenging lesions when dealing with periodontal regenerative procedures. In fact, their non-containing morphology does not contribute wound stability, and the wou...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA Patient-specific
- age≥ 18 years;
- diagnosis of Stage III or IV periodontitis22;
- good physical status (ASA1 and ASA2 according to Physical Status Classification System);
- systemic and local conditions compatible with periodontal surgical procedures;
- patient willing and fully capable to comply with the study protocol.
- Site-specific
- defect located in an incisor, canine or premolar region which becomes exposed during spontaneous smiling;
- defect with an intrabony component (as assessed on periapical radiograph and confirmed intra-surgically) ≤ 2 mm;
- defect with a radiographic CEJ-BC≥ 4 mm; d) residual (following step I-II of treatment) PD≥6 mm at both interproximal aspects facing the SD.
- EXCLUSION CRITERIA Patient-specific
- poorly controlled diabetes (HbA1C ≥ 7%);
- history of radiation therapy in the head and neck area;
- history of chemotherapy;
- systemic disease or conditions with a documented effect on bone metabolism and/or periodontal status/healing;
- past (within 6 months prior to enrollment in the study) or current treatment with any medication with a documented effect on bone metabolism and/or periodontal status/healing;
- physical or mental handicap that can interfere with adherence to the study procedures and adequate hygienic compliance;
- documented allergy to dental materials involved in the experimental protocol;
- pregnancy or lactation;
- history of drug or alcohol abuse.
- Moreover, participants will be immediately excluded from the study:
- upon request to withdraw from further participation;
- development of acute dental/periodontal or oral conditions requiring treatment;
- development of conditions conflicting with the exclusion criteria listed above
- failure to comply with study instructions/requirements.
- Site-specific
- presence of untreated endodontic lesions or inadequate endodontic treatment of teeth facing the SD;
- presence of orthodontic appliances;
- local conditions preventing proper plaque control at experimental sites;
- grade III mobility.
Exclusion
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06897085
Start Date
April 1 2025
End Date
December 30 2026
Last Update
April 1 2025
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