Efficacy of a Gel Containing Polynucleotides and Hyaluronic Acid in Supraosseous Periodontal Defects Treated with the Single Flap Approach

Launched by AZIENDA UNITÀ SANITARIA LOCALE (A.U.S.L.) FERRARA, ITALY · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with a specific type of gum disease called periodontitis, particularly focusing on areas of the mouth that are visible when you smile. The researchers want to see if using a special gel that contains polynucleotides and hyaluronic acid, combined with a surgical technique called the Single Flap Approach, can improve healing in these challenging areas. They will compare the results of this treatment to patients who only receive the surgical procedure without the gel, looking at both how well the gums heal and how patients feel about their appearance and tooth sensitivity after six months.

To participate in this trial, individuals must be at least 18 years old and diagnosed with advanced periodontitis. They should be in generally good health and have specific gum defects located in the front part of the mouth. Certain health conditions, like uncontrolled diabetes or recent chemotherapy, would exclude someone from joining. Participants can expect to undergo a minimally invasive procedure and will be monitored for their healing and satisfaction with the results. This study aims to improve both the health and aesthetic outcomes for patients dealing with gum issues in visible areas.

Gender

ALL

Eligibility criteria

• • 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.