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NCT Number: NCT07212270

Effectiveness of Intraseptal Anesthesia for Periodontal Surgical Procedures

The primary aim of this study is to evaluate the efficacy of intraseptal anesthesia using 0.3 mL of 4% articaine with 1:100,000 epinephrine (4% Ar+Ep) for periodontal flap surgery in patients with periodontitis and for gingivectomy/ gingivoplasty for the excision of hyperplastic gingival enlargements. The secondary aim is to compare clinical anesthetic parameters between the ISA and conventional anesthesia techniques.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Periodontitis Gingival Diseases Gingivitis Gingivitis and Periodontal Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

About this study

In the test groups every patient is going to receive injections of 0.3 mL of 4% articaine with 1: 100,000 epinephrine (ORABLOC ® , 40 mg/ml Articaine + 0.01 mg/ml Epinephrine, PIERREL S.P.A, Capua, Italy), with a computer controlled anesthesia delivery system (Anaeject®, Septodont, Sallanches, France). In the control groups all surgical procedures is going to be performed under infiltration anesthesia, as commonly used in periodontal surgery. The success rate and the anesthetic field widths is going to be recorded by pinprick testing. The pain levels will be recorded using the Visual Analogue Scale (VAS) for the administration of anesthesia, during the surgical procedure and after the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥18 years good systemic health
  • gingivitis or periodontitis stage II and III
  • at least 20 teeth present.

Exclusion criteria

  • allergy to 4%Ar+Ep
  • pregnant or lactating females
  • medication uptake and diseases affecting the periodontal tissues
  • acute pain, swelling, and presence of gingival lesions.

Treatment and study plan

Periodontal flap surgery

Procedure

Open flap debridement with intra-sulcular incisions or flaps with para-marginal incisions were performed by lifting the mucoperiosteal flap and debriding the periodontal defect under visual control.

gingivectomy and gingivoplasty

Procedure

surgical methods for the excision of hyperplastically enlarged gingiva.

Primary outcomes

  1. The anesthetic efficacy

    Time frame: 5 min after injection

    The absence of pain for two pinprick tests in a row.

  2. The width of the anesthetic field on the buccal side

    Time frame: 5 min after injection

    maximal distance between the two painless needle's pricks on the buccal aspect of attached gingiva

  3. The width of the anesthetic field on oral side

    Time frame: 5 min after injection

    The maximal distance between the two painless needle's pricks on the oral aspect of the attached gingiva.

  4. VASa

    Time frame: immediately after anesthetic administration

    The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable.

  5. VASi

    Time frame: at the end of the treatment

    The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable.

  6. VASp

    Time frame: one day follow-up

    The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable.

  7. The duration

    Time frame: form start to finish od intervention

    The duration of intervention, measured in minutes.

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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