Comparative Evaluation of Microsurgery vs Conventional Surgical Technique of Gingival Depigmentation

NCT05930392 | Unknown DMC

• 1 other identifier: AANCHALSAHNIPERIO2
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Gingiva being the most frequently pigmented tissue of the oral cavity challenges a lot of people with an esthetic concern. Increased production of melanin, a pigment produced by the melanocytes present in the basal and suprabasal cell layers of the epithelium leads to the hyper-pigmented appearance. Over the decades many non-surgical as well as surgical techniques have been developed to manage the melanin induced hyper-pigmentation of gingival tissue with comparable efficacies. Till date, the most common gingival depigmentation procedure with satisfactory results remains the conventional scalpel (#15 blade) method. Nowadays, minimally traumatising the surgical field and gaining maximum outputs with help of microscopy and microsurgical instruments has attained a level of utmost importance in surgical procedures including periodontal therapy. Improved results in terms of increased vascularization of the grafts, relatively better percentages of root coverage a significant increase in width and thickness of keratinized tissue, an improved esthetic outcome and decreased patient morbidity in cases of gingival recession treated via microsurgical approach have been observed and well documented. However, perusal of the literature available suggests that clinical outcomes and esthetic potential of the results of gingival depigmentation using principles of microsurgery is an area of interest that still needs to be explored further. This study is therefore aimed at evaluating and comparing the clinical, esthetic and patient-related outcomes of gingival depigmentation performed using microsurgery vs conventional surgical technique.

Conditions

Gingival Pigmentation; Melanosis

Outcome Measures

Primary Outcomes (9)

• CLINICAL PARAMETER- Bleeding

  bleeding score classified in accordance to Ishi et al and Kawashima et al A: NONE B: SLIGHT C: MODERATE D: SEVERE

  3 MONTHS

• CLINICAL PARAMETER- REDNESS

  redness score classified in accordance to Ishi et al and Kawashima et al A: NONE B: SLIGHT C: MODERATE D: SEVERE

  3 MONTHS

• CLINICAL PARAMETER- swelling

  swelling score classified in accordance to Ishi et al and Kawashima et al A: NONE B: SLIGHT C: MODERATE D: SEVERE

  3 MONTHS

• CLINICAL PARAMETER- WOUND HEALING

  Wound healing score classified in accordance to Ishi et al and Kawashima et al A: COMPLETE EPITHELIALIZATION B: INCOMPLETE OR PARTIAL EPITHELIALIZATION C: ULCER D: TISSUE DEFECT OR NECROSIS

  3 MONTHS

• CLINICAL PARAMETER- Gingival color

  Gingival Color A: IMPROVEMENT B: SLIGHT IMPROVEMENT C: NO CHANGE D: DETERIORATION

  3 MONTHS

• DUMMETT ORAL PIGMENTATION INDEX (DOPI)

  DOPI Score Criteria 0 Pink tissue (no clinical pigmentation) 1. Mild light brown tissue (mild clinical pigmentation) 2. Medium brown or mixed brown and pink tissue (moderate clinical pigmentation) 3. Deep brown/ blue-black tissue (heavy clinical pigmentation)

  3 MONTHS

• HEDIN MELANIN INDEX (HMI)

  HMI Score Criteria 0 No pigmentation 1. One or two solitary units of pigmentation in the papillary gingiva 2. \>3 units of pigmen- tation in the papillary gingiva without formation of a continuous ribbon 3. More than equal to 1 short continuous ribbons of pigmentation 4. One continuous ribbon including the entire area between the canines

  3 MONTHS

• Patient-related outcome measures (PROMs) - post-operative pain perception

  Pain will be assessed on a 100-mm horizontal, continuous interval scale with the left endpoint marked ''no pain'' and the right endpoint marked ''worst pain.'' The patient placed a mark to coincide with the level of pain. Scores were calculated as: 0 = no pain; 0.1 to 3.0 cm (1 to 30 mm) = slight pain; 3.1 to 6.0 cm (31 to 60 mm) = moderate pain; 6.1 to 10 cm (61 to 100 mm) = severe pain.

  3 months

• Patient-related outcome measures (PROMs) - ESTHETIC SATISFACTION

  ESTHETIC SATISFACTION WILL BVE EVALUATED AS PER PATIENT'S RESPONSE TO PREFERRED CHOICE OF TREATMENT - CONVENTIONAL OR MICROSURGICAL

  3 months

Secondary Outcomes (7)

• MELANOCYTE HISTOPATHOLOGIC COUNT (MHC)

  3 MONTHS

• PERIODONTAL PARAMETER - PLAQUE INDEX

  3 MONTHS

• PERIODONTAL PARAMETERS - GINGIVAL INDEX,

  3 MONTHS

• PERIODONTAL PARAMETERS - BLEEDING ON PROBING (BOP)

  3 MONTHS

• PERIODONTAL PARAMETER - PROBING POCKET DEPTH (PPD)

  3 MONTHS

Study Arms (2)

GINGIVAL DEPIGMENTATION USING MICROSURGERY

ACTIVE COMPARATOR

Surgical excision of hyper-pigmented gingival tissue using microsurgical blade (keratome 2.2) and magnification loupes under local anaesthesia. Application of periodontal dressing followed by post-operative instructions.

Procedure: Gingival depigmentation using microsurgery

Conventional surgical technique of gingival depigmentation

ACTIVE COMPARATOR

Surgical excision of hyper-pigmented gingival tissue using conventional surgical blade (#15) under local anaesthesia. Application of periodontal dressing followed by post-operative instructions.

Procedure: Conventional surgical depigmentation

Interventions

Gingival depigmentation using microsurgery PROCEDURE

GINGIVAL DEPIGMENTATION USING MICROSURGICAL BLADE AND MAGNIFICATION LOUPES

GINGIVAL DEPIGMENTATION USING MICROSURGERY

Conventional surgical depigmentation PROCEDURE

GINGIVAL DEPIGMENTATION USING CONVENTIONAL SURGICAL TECHNIQUE

Conventional surgical technique of gingival depigmentation

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• )Systemically healthy patients seeking treatment for gingival hyper-pigmentation

You may not qualify if:

• Gingival index (Loe and Sillness 1963) of greater than or equal to 1 at any site of surgical field.
• patients with periodontitis
• patients with pathologic or drug-induced gingival hyper-pigmentation
• patients with history of systemic illness with the potential to influence the periodontal status or outcome of periodontal intervention;
• patients with Miller Grade II /Grade III tooth mobility;
• patients taking medications such as NSAIDS, corticosteroids, statins or calcium channel blockers, which are known to influence periodontal status;
• pregnant or lactating women;
• history of use of tobacco;

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• AANCHAL SAHNI, BDS

  POST GRADUATE INSTITUTE OF DENTAL SCIENCES,ROHTAK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RAJINDER KR SHARMA, MDS

CONTACT

9416358222; rksharmamds@yahoo.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: July 5, 2023
• Study Start: July 1, 2023
• Primary Completion: September 25, 2023
• Study Completion: October 10, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-06

Locations

IN (1)