- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05930392
Comparative Evaluation of Microsurgery vs Conventional Surgical Technique of Gingival Depigmentation
Comparative Evaluation of Microsurgery vs Conventional Surgical Technique of Gingival Depigmentation on Pink Esthetics and Patient-related Outcomes: A Split-mouth Randomised Controlled Clinical Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
AIM: To evaluate and compare the clinical, esthetic and patient-related outcomes of gingival depigmentation performed via microsurgery vs conventional surgical technique.
OBJECTIVES:
- To evaluate and compare melanin pigmentation using Dummett Oral Pigmentation Index (DOPI), Hedin melanin index (HMI) between both the treatment modalities at baseline, 1 week, 1 month and 3 months post-operatively.
- To assess a) patient-related outcome measures (PROMs) such as post-operative pain perception/discomfort on a visual analog scale (VAS) , patient's preference of the mode of treatment /esthetic satisfaction and b) clinical parameters such as bleeding, redness, swelling, wound healing, gingival colour, gingival morphology at baseline, within 24 hours, 1 week, 1 month and 3 months.
- To evaluate the effect of different treatment modalities on melanocyte histopathologic count (MHC).
TIME FRAME: 3 months SAMPLE SIZE: To achieve a power of 80%, level of significance of 5% and assuming an effect size of 0.8, a minimum sample size of 18 patients is needed in each group. Accounting for a 20% drop out rate, 22 patients are needed in each group.
METHODOLOGY: Patients fulfilling the eligibility criteria will be enrolled in the study after obtaining an informed written consent. A split-mouth design with maxillary and mandibular anteriors being randomly allocated into test (microsurgery) and control (conventional surgical depigmentation) technique to each patient using a radio-opaque box having 44 chits.
STATISTICAL ANALYSIS: Data recorded will be processed by standard statistical analysis. The normality of distribution of data will be examined by Shapiro Wilk test. Statistical analysis will be performed according to distribution of data. If it is in normal distribution, intra group comparison will be done by paired t-test between two time points and inter group comparison will be done by using unpaired t-test between two groups. If it is in non-normal distribution, intra group comparison will be done by Wilcoxon signed rank test and inter group comparison will be done by Mann-Whitney U test.
SETTING: Department of Periodontology and Oral Implantology, PGIDS, Rohtak, Haryana.
STUDY DESIGN: Split-mouth Comparative Randomised Controlled Clinical Study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: RAJINDER KR SHARMA, MDS
- Phone Number: 9416358222
- Email: rksharmamds@yahoo.in
Study Locations
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- Post Graduate Institute of Dental Sciences
-
Contact:
- RAJINDER KR SHARMA, MDS
- Phone Number: 9416358222
- Email: rksharmamds@yahoo.in
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1)Systemically healthy patients seeking treatment for gingival hyper-pigmentation
Exclusion Criteria:
- 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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: GINGIVAL DEPIGMENTATION USING MICROSURGERY
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.
|
GINGIVAL DEPIGMENTATION USING MICROSURGICAL BLADE AND MAGNIFICATION LOUPES
|
Active Comparator: Conventional surgical technique of gingival depigmentation
Surgical excision of hyper-pigmented gingival tissue using conventional surgical blade (#15) under local anaesthesia.
Application of periodontal dressing followed by post-operative instructions.
|
GINGIVAL DEPIGMENTATION USING CONVENTIONAL SURGICAL TECHNIQUE
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DUMMETT ORAL PIGMENTATION INDEX (DOPI)
Time Frame: 3 MONTHS
|
DOPI Score Criteria 0 Pink tissue (no clinical pigmentation)
|
3 MONTHS
|
HEDIN MELANIN INDEX (HMI)
Time Frame: 3 MONTHS
|
HMI Score Criteria 0 No pigmentation
|
3 MONTHS
|
CLINICAL PARAMETER- Bleeding
Time Frame: 3 MONTHS
|
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
Time Frame: 3 MONTHS
|
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
Time Frame: 3 MONTHS
|
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
Time Frame: 3 MONTHS
|
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
Time Frame: 3 MONTHS
|
Gingival Color A: IMPROVEMENT B: SLIGHT IMPROVEMENT C: NO CHANGE D: DETERIORATION |
3 MONTHS
|
Patient-related outcome measures (PROMs) - post-operative pain perception
Time Frame: 3 months
|
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
Time Frame: 3 months
|
ESTHETIC SATISFACTION WILL BVE EVALUATED AS PER PATIENT'S RESPONSE TO PREFERRED CHOICE OF TREATMENT - CONVENTIONAL OR MICROSURGICAL
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MELANOCYTE HISTOPATHOLOGIC COUNT (MHC)
Time Frame: 3 MONTHS
|
EFFECT ON MELANOCYTE HISTOPATHOLOGIC COUNT The activity of the melanocytes will be measured at baseline and 3 months post-operatively, by microscopically viewing the density of melanin granules.35 The grading will be done using the following scale: 0 = absence of melanin granules (no pigmentation); 1 = rare and scattered melanin granules (mild pigmentation); 2 = dense but not aggregated melanin granules (moderate pigmentation); or 3 = dense and aggregated melanin granules (heavy pigmentation). |
3 MONTHS
|
PERIODONTAL PARAMETER - PLAQUE INDEX
Time Frame: 3 MONTHS
|
PLAQUE INDEX " SCORE" "CRITERIA" 0 No plaque
|
3 MONTHS
|
PERIODONTAL PARAMETERS - GINGIVAL INDEX,
Time Frame: 3 MONTHS
|
GINGIVAL INDEX Score Criteria 0 Absence of inflammation/normal gingiva.
|
3 MONTHS
|
PERIODONTAL PARAMETERS - BLEEDING ON PROBING (BOP)
Time Frame: 3 MONTHS
|
BLEEDING ON PROBING BOP will be recorded as 1 (present) if it occurs within 15 secs of probing and 0 (absent) if no bleeding occurs. It will be calculated in %. After adding all the scores, total score will be divided by the total number of surfaces accessed and multiplied by 100. It will be designed as % sites |
3 MONTHS
|
PERIODONTAL PARAMETER - PROBING POCKET DEPTH (PPD)
Time Frame: 3 MONTHS
|
PROBING POCKET DEPTH Probing pocket depth will be measured as the distance from the gingival margin to the base of pocket. The probing depth measurements will be assessed using a calibrated manual periodontal probe (PCP-UNC 15 Hu-Friedy, Chicago, IL, USA). The probe will be inserted with a firm, gentle pressure to the bottom of the pocket and maintained parallel to the vertical axis of the tooth. Measurements will be noted at 6 sites of each tooth - mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual. Measurements will be rounded to the nearest whole millimetre. |
3 MONTHS
|
PERIODONTAL PARAMETER - CLINICAL ATTACHMENT LEVEL (CAL)
Time Frame: 3 MONTHS
|
CLINICAL ATTACHMENT LEVEL Clinical Attachment Level will be measured as the distance between the base of the pocket and the cemento-enamel junction (CEJ).
Measurements will be made at 6 sites of each tooth- mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual using UNC-15 probe.
|
3 MONTHS
|
PERIODONTAL PARAMETERS - GINGIVAL RECESSION (GR)
Time Frame: 3 MONTHS
|
GINGIVAL RECESSION Recession will be measured as the vertical distance from the CEJ to the deepest part of gingival margin in the middle of the buccal aspect of the crown. |
3 MONTHS
|
Collaborators and Investigators
Investigators
- Principal Investigator: AANCHAL SAHNI, BDS, Post Graduate Institute Of Dental Sciences,Rohtak
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AANCHALSAHNIPERIO2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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