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NCT Number: NCT04542486

Clinical Efficacy of Soft Tissue Trimmer in Cases of Gingival Hyperplasia.

Postoperative pain and wound healing are compared after using conventional scalpel technique in comparison with the intervention which is using Soft tissue Trimmer for cases of gingival hyperplasia.

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Key information

Conditions

Pain, Postoperative Gingival Diseases Gingival Hyperplasia Gingival Overgrowth Mouth Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Postoperative Complications Signs and Symptoms Stomatognathic Diseases Wound Heal

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine-CU

Cairo, Egypt

About this study

In the control group:

  • Following the local anaesthetic administration, A reverse bevel gingivectomy will be performed with a #15c scalpel.
  • The borderline of gingiva will be determined via the use of a pointer dental tweezers, and excessive gingival tissue will then be removed with Gracey curettes
  • No periodontal packs to be applied to ensure accurate evaluations of follow-up pain and wound healing

In the intervention group:

  • Following the local anaesthetics administration for the Soft tissue trimmer(STT) gingivectomies, Soft tissue trimmer will be used with 400-rpm rotary systems and with no serum irrigation, per the manufacturer's recommendation.
  • Gingivoplasties will be performed with the same Soft tissue trimmer to easily provide a knife-edge appearance.
  • No periodontal packs will be applied to ensure accurate evaluations of follow-up pain and wound healing.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Anterior region (minimum of four teeth at each surgical site)
  • Age range (18-45) years old
  • Plaque-induced inflammatory gingival enlargement
  • Altered passive eruption
  • No clinical attachment loss
  • Systemically healthy individuals

Exclusion criteria

  • Gingival enlargement due to any systemic predisposing factors
  • Pregnancy and/or lactation
  • Allergy
  • Conditions requiring antibiotic prophylaxis and anti-inflammatory medications.
  • Acute or untreated periodontitis
  • Systemic disease that could influence the outcome of the treatment (i.e. Diabetes)

Treatment and study plan

Excision of gingival hyperplasia using "Soft tissue trimmer ".

Procedure

Gingivoplasties and removal of excess gingival tissues using Soft tissue trimmer.

Excision of gingival hyperplasia using the conventional scalpel technique

Procedure

Excision of gingival hyperplasia in gingivoplasties using the conventional technique reverse bevel using 15c blade.

Primary outcomes

  1. Pain VAS

    Time frame: 7 days

    Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured 1,3,5 and 7 days postoperatively.

Secondary outcomes

  1. Epithelization

    Time frame: 14 days.

    Re-epithelization after removal of excess tissue will be assessed either partial or complete.This will be tested by toluidine blue (TB)

  2. Tissue colour

    Time frame: 6 weeks.

    If it is either redder or whiter than the opposite side, or like opposite side tissue.

  3. Bleeding

    Time frame: From 3-5 days

    If bleeding spontaneously or on palpation exists or not.

  4. Surgical time

    Time frame: During surgical procedure itself.

    Time taken for both groups of surgery( control and intervention) will be measured from the administration of anaesthesia till removal of excess tissues.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Efficacy of Soft Tissue Trimmer on Postoperative Pain and Wound Healing When Compared to the Conventional Surgical Excision of Gingival Hyperplasia: A Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2020
Registry last updated
Apr 13, 2022

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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