Effectiveness of Intraseptal Anesthesia for Periodontal Surgical Procedures

NCT07212270 | Active Not Recruiting

• 1 other identifier: UBelgrade 36/8 (2)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis; Gingivitis and Periodontal Diseases

Outcome Measures

Primary Outcomes (7)

• The anesthetic efficacy

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

  5 min after injection

• The width of the anesthetic field on the buccal side

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

  5 min after injection

• The width of the anesthetic field on oral side

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

  5 min after injection

• VASa

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

  immediately after anesthetic administration

• VASi

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

  at the end of the treatment

• VASp

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

  one day follow-up

• The duration

  The duration of intervention, measured in minutes.

  form start to finish od intervention

Study Arms (4)

GG test

EXPERIMENTAL

Patient subjected to gingivectomy and gingivoplasty interventions and anesthesia of choice is intraseptal anesthesia.

Procedure: gingivectomy and gingivoplasty

GG control

ACTIVE COMPARATOR

Patient subjected to gingivectomy and gingivoplasty interventions under the local infiltration anesthesia.

Procedure: gingivectomy and gingivoplasty

PF test

EXPERIMENTAL

Patients undergoing periodontal flap surgery under the intraseptal anesthesia.

Procedure: periodontal flap surgery

PF control

ACTIVE COMPARATOR

Patients undergoing periodontal flap surgery under the local infiltration anesthesia.

Procedure: periodontal flap surgery

Interventions

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.

PF control; PF test

gingivectomy and gingivoplasty PROCEDURE

surgical methods for the excision of hyperplastically enlarged gingiva.

GG control; GG test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

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

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Periodontitis; Gingivitis; Periodontal Diseases

Interventions

Gingivectomy; Gingivoplasty

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Periodontics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Periodontist do not know the type of anesthesia given by the investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 2 parallel groups, each with the experimental and the control group

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 8, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

SE (1)