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Search / Trial NCT06201377

Analysis of Early Healing of Sutures in Periodontal Surgery

Launched by ANA MARÍA GARCÍA DE LA FUENTE · Dec 30, 2023

Trial Information

Current as of November 14, 2025

Enrolling by invitation

Keywords

Surgical Site Infection Periodontal Surgery Post Surgical Pain Post Surgical Inflammation Periodontitis

ClinConnect Summary

This small, pilot study is looking at whether using a chlorhexidine-coated absorbable suture during periodontal (gum) surgery helps healing happen better than a standard absorbable suture without chlorhexidine. In a randomized, triple-minded design, adult patients needing periodontal surgery will receive either the chlorhexidine suture or the standard suture. The main question is how well the gum tissue heals, measured with a healing index at 7 days, 14 days, 1 month, and 2 months after surgery. Researchers will also collect several secondary pieces of information, such as pain before and after surgery, signs of inflammation, how well the wound closes during surgery, any post-surgical problems, plaque on the suture, suture looseness, pain at suture removal, and analyses of the suture knot itself.

About 60 adults (18 years and older) who have completed the basic gum-care phase and need periodontal surgery will be eligible. Key inclusion criteria include having low plaque and bleeding scores and being generally healthy enough for surgery. Exclusions include conditions that would make surgery unsafe, allergies to chlorhexidine or certain solvents, NSAID allergy, pregnancy, certain advanced gum defects, or recent antibiotic use (within 3 months). The study is being conducted at the University of the Basque Country in Leioa, Spain, and participants, as well as most researchers assessing outcomes, won’t know which suture was used to keep the results unbiased. If you enroll, you can expect follow-up visits to check healing and a short pain diary for the first week after surgery, with results reported after the study finishes.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients ≥ 18 years-old
  • Patients who have completed the basic periodontal phase and require surgical periodontal treatment for periodontal disease control.
  • Plaque index (O'Leary et al.,1972) ≤20%.
  • Bleeding index (Ainamo \& Bay,1975) ≤20%.
  • Exclusion Criteria:
  • Patients with systemic conditions contraindicating surgery
  • Patients with allergy to chlorhexidine and/or o-cymen-5-ol
  • Patients allergic to non-steroidal anti-inflammatory drugs (NSAIDs)
  • Pregnant or breastfeeding women
  • Patients with periodontal defects requiring regenerative surgery or mucogingival surgery/periodontal plastic therapy
  • Patients who have taken antibiotics in the last 3months

About Ana María García De La Fuente

Ana María García de la Fuente is a distinguished clinical trial sponsor known for her commitment to advancing medical research and innovation. With a robust background in clinical pharmacology and a keen focus on patient-centric approaches, she has successfully led numerous trials across various therapeutic areas. Her expertise in regulatory compliance and strategic trial design ensures that studies are conducted with the highest ethical standards, prioritizing participant safety and data integrity. Ana María's collaborative leadership style fosters partnerships with research institutions and healthcare professionals, driving the development of groundbreaking therapies that improve patient outcomes.

Locations

Leioa, Biscay, Spain

Patients applied

0 patients applied

Trial Officials

Ana María García-De-La-Fuente, phD

Study Director

University of the Basque Country (UPV/EHU)

Aitziber Fernández-Jiménez, phD

Principal Investigator

University of the Basque Country (UPV/EHU)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported