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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04542486
Enrollment
28
Registered
2020-09-09
Start date
2021-01-28
Completion date
2021-07-01
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Hyperplasia, Pain, Postoperative, Wound Heal

Brief summary

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.

Detailed description

In the control group: 1. Following the local anaesthetic administration, A reverse bevel gingivectomy will be performed with a #15c scalpel. 2. 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 3. No periodontal packs to be applied to ensure accurate evaluations of follow-up pain and wound healing In the intervention group: 1. 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. 2. Gingivoplasties will be performed with the same Soft tissue trimmer to easily provide a knife-edge appearance. 3. No periodontal packs will be applied to ensure accurate evaluations of follow-up pain and wound healing.

Interventions

PROCEDUREExcision of gingival hyperplasia using Soft tissue trimmer .

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

PROCEDUREExcision of gingival hyperplasia using the conventional scalpel technique

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Pain VAS7 daysVisual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured 1,3,5 and 7 days postoperatively.

Secondary

MeasureTime frameDescription
Epithelization14 days.Re-epithelization after removal of excess tissue will be assessed either partial or complete.This will be tested by toluidine blue (TB)
Tissue colour6 weeks.If it is either redder or whiter than the opposite side, or like opposite side tissue.
BleedingFrom 3-5 daysIf bleeding spontaneously or on palpation exists or not.
Surgical timeDuring 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026