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OpenTrials
Completed

NCT Number: NCT05460988

"Re-instrumentation vs Flap Surgery"

There are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets.

The aim of this RCT is to compare the re-instrumentation vs the flap surgery in terms of PD reduction, CAL gain, gingival recession, need of an additional surgery and pocket closure. Moreover, PROMs will be evaluated

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Key information

Conditions

Periodontal Pocket Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florence

Florence, 50134, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18aa
  • Patients with periodontal disease
  • Less than 20 cigarettes/day
  • No systemic antibiotic therapy in the last 3 months
  • At least one interdental site showing PD≥5mm after the non surgical periodontal initial therapy. Infrabony component of the defect ≤3mm at x-ray
  • Full-mouth plaque score and full-mouth bleeding score <15% at baseline (re-evaluation) measured at six sites per tooth
  • No previous periodontal surgery at the experimental tooth

Exclusion criteria

  • Connective tissue diseases
  • Diabetes
  • Pregnancy or lactating
  • Furcation involvement
  • Crowned tooth
  • Severe tooth mobility (class III)
  • Radiographical horizontal bone resorption exceeding the 50% of the root

Treatment and study plan

Flap surgery

Procedure

All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0).

Non surgical re-instrumentation

Procedure

The sites showing remaining pockets (PD>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes.

Primary outcomes

  1. PD change

    Time frame: 3 months after the procedure

    change in periodontal probing depth (in mm)

  2. PD change

    Time frame: 6 months after the procedure

    change in periodontal probing depth (in mm)

  3. PD change

    Time frame: 12 months after the procedure

    change in periodontal probing depth (in mm)

Secondary outcomes

  1. CAL change

    Time frame: 3 months after the procedure

    change in clinical attachment level (in mm)

  2. CAL change

    Time frame: 6 months after the procedure

    change in clinical attachment level (in mm)

  3. CAL change

    Time frame: 12 months after the procedure

    change in clinical attachment level (in mm)

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

"Re-instrumentation vs Flap Surgery in Residual Pockets: a RCT on Clinical Efficacy"

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 15, 2022
Registry last updated
Apr 10, 2025

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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