Treatment of gum defects using hyaluronic acid and polynucleotides

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to investigate the early molecular events in wound healing and the vascularization patterns associated with treating supra-bony defects in periodontitis patients. Participants will undergo a parallel-group intervention involving either a periodontal access flap alone or in combination with a gel formulation of hyaluronic acid and polydeoxyribonucleotides. The study will involve up to 24 patients over a minimum period of 4 months, with a total of 7 visits to assess the outcomes. The research is being conducted at the Centre for Oral Clinical Research at Queen Mary University of London.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Systemically healthy males and females ≥18 years old
* Stage III or IV periodontitis (Papapanou, Sanz et al. 2018)
* Presence of supra-bony periodontal defects (i.e., defects where the base of the pocket is located coronal to the alveolar crest and characterized by a predominantly horizontal pattern of tissue destruction) confirmed clinically and radiographically at a minimum of two and a maximum of four adjacent teeth and with a probing pocket depth (PPD) \> 5 mm, following non-surgical periodontal therapy (NSPT). If \>4 adjacent teeth exhibited the above clinical and radiographic conditions, the four adjacent teeth showing the greatest overall loss of periodontal attachment were included. Wisdom teeth and second molars will not be considered for the study.

If defect presents with an intrabony component, this should be ≤2 mm.

* Non-surgical periodontal treatment (step 1 and 2) completed within the previous 4 months
* Full-mouth bleeding score (FMBS) and full-mouth plaque score (FMPS) ≤20%

Exclusion Criteria:

* Teeth with degree III mobility
* Multi-rooted teeth with grade ≥2 furcation involvement
* Heavy smokers (≥10 cigarettes a day)
* Untreated caries or endodontic lesions or abscesses on the teeth involved in the surgery
* Previous periodontal surgery in the area selected for the study
* History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures (e.g., mitral valve prolapse, artificial heart)
* Antibiotic or anticoagulant therapy during the month preceding the baseline exam.
* History of alcohol or drug abuse
* Medical history that includes uncontrolled diabetes or hepatic or renal diseases, or other serious medical conditions that can have a negative impact on the periodontal condition
* In treatment with medications that can severely affect bone metabolism and blood clot formation (e.g., anticoagulants, long-term corticosteroids, bisphosphonates, immunosuppressants)
* Self-reported pregnancy or lactation.

Where it's running

• Barts Health NHS Trust Dental Hospital
  London, United Kingdom Recruiting
• Centre for Oral Clinical Research (COCR)
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Elena Calciolari, DDS, MS, PhD — Qmul
• Study coordinator: Miljana Bacevic
• Email: BHNT.Clinicaloralresearchcentre@nhs.net
• Phone: +442078823063

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing three types of papilla incision techniques in periodontal surgery

  This study is testing three different ways to make cuts in the gums during periodontal surgery to see which method works best for treating gum disease.

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• Comparing two surgical methods for treating periodontitis

  This study tests which of two surgical methods works better for people with periodontitis who still have deep pockets around their teeth after initial treatment.

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• Biologic agents added to non-surgical periodontal therapy for intrabony defects

  This study tests whether adding rhPDGF, L-PRF, or enamel matrix derivatives to minimally invasive non-surgical therapy helps restore deep bone defects in periodontitis patients.

  Recruiting G. d'Annunzio University · Tirana · NCT05858411

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.