Gingival PigmentationNCT05930366
Comparative Evaluation of Microsurgery vs Diode Laser Technique of Gingival Depigmentation
A study testing Gingival depigmentation using microsurgery and Gingival Depigmentation using Diode Laser in people with Gingival Pigmentation and Melanosis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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 of these tissues. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Pigmentation, Melanosis
- What is being tested?
- Gingival depigmentation using microsurgery and Gingival Depigmentation using Diode Laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2023to 29 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Systemically healthy patients seeking treatment for gingival hyper-pigmentation.
Who cannot join
- Gingival index (Leo and silliness 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;
Show all 10Show fewer
- Patients taking medications such as NSAIDS, corticosteroids, statins or calcium 8
- Channel blockers, which are known to influence periodontal status;
- Pregnant or lactating women;
- History of use of tobacco;
Trial locations and contacts
1 site in 1 country.
India1 site
Post graduate institute of dental sciences
Rohtak, Haryana, 110015
Ritika Arora, 09810734445, drritika44@gmail.com
About this study
Official title: Comparative Evaluation of Microsurgery vs Diode Laser Technique of Gingival Depigmentation on Pink Esthetics and Patient-related Outcomes: A Split-mouth Randomised Controlled Clinical Study.
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 of these tissues. Over the decades many non-surgical as well as surgical techniques have been developed to remove the melanin induced hyper-pigmentation of gingival tissue with comparable efficacies. The surgical treatment modalities include use of scalpel, laser ablation, bur abrasion, electrocautery, cryosurgery, radio-surgery, free gingival grafts and acellular dermal matrix allograft etc. Diode lasers have frequently been used in a variety of soft tissue surgical procedures and have many advantages such as less pain, bleeding, scar formation and infection. Examined histologically, laser wounds have been resulted in less wound contracture or scarring, and ultimately improved healing. Depigmentation with lasers has become popular in recent times due to good results but requires sophisticated equipment and occupies a large space. Therefore the most practical gingival depigmentation procedure, both patient and operator wise, 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 diode laser technique.
Read the detailed description
AIM: To evaluate and compare the clinical, esthetic and patient-related outcomes of gingival depigmentation performed via Microsurgery vs Diode Laser 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 parameters13 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).
SETTING: Department of Periodontology and Oral Implantology, PGIDS, Rohtak, Haryana.
STUDY DESIGN: Split-mouth Comparative Randomised Controlled Clinical Study. 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 with a chief complaint of unpleasant appearance of gingival tissue will be recruited from the outpatient Department of Periodontology, PGIDS, Rohtak. 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 (Diode laser technique) group to each patient using a chit method.
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.
- Conditions
- Gingival Pigmentation, Melanosis
- Being tested
- Gingival depigmentation using microsurgery, Gingival Depigmentation using Diode Laser
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival depigmentation using microsurgeryProcedure or surgery
GINGIVAL DEPIGMENTATION USING MICROSURGICAL BLADE AND MAGNIFICATION LOUPES
Gingival Depigmentation using Diode LaserProcedure or surgery
GINGIVAL DEPIGMENTAION USING DIODE LASER
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Gingival depigmentation using microsurgery |
| Gingival Depigmentation using Diode Laser | Active comparator | Ablation of hyper-pigmented gingival tissue using Diode Laser under local anaesthesia. Receives: Procedure: Gingival Depigmentation using Diode Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLINICAL PARAMETER- BLEEDING
Bleeding score classification in accordance to Ishi et al and Kawashima et al
A: NONE B: SLIGHT C: MODERATE D: SEVERE
Measured: 3 MONTHS
CLINICAL PARAMETER- REDNESS
Redness score classification in accordance to Ishi et al and Kawashima et al
A: NONE B: SLIGHT C: MODERATE D: SEVERE
Measured: 3 MONTHS
CLINICAL PARAMETERS- SWELLING
Swelling score classification in accordance to Ishi et al and Kawashima et al
A: NONE B: SLIGHT C: MODERATE D: SEVERE
Measured: 3 MONTHS
CLINICAL PARAMETER- WOUND HEALING
wound healing score classification in accordance to Ishi et al and Kawashima et al
A: COMPLETE EPITHELIALIZATION B: INCOMPLETE OR PARTIAL EPITHELIALIZATION C: ULCER D: TRISSUE EFECT OR NECROSIS
Measured: 3 MONTHS
CLINICAL PARAMETER- GINGIVAL COLOR
gingival color score classification in accordance to Ishi et al and Kawashima et al
A: IMPROVEMENT B: SLIGHT IMPROVEMENT C: NO CHANGE D: DETERIORATION
Measured: 3 MONTHS
DUMMETT ORAL PIGMENTATION INDEX (DOPI)
DOPI
Score Criteria 0 Pink tissue (no clinical pigmentation)
- Mild light brown tissue (mild clinical pigmentation)
- Medium brown or mixed brown and pink tissue (moderate clinical pigmentation)
- Deep brown/ blue-black tissue (heavy clinical pigmentation)
Measured: 3 MONTHS
HEDIN MELANIN INDEX (HMI)
HMI
Score Criteria 0 No pigmentation
- One or two solitary units of pigmentation in the papillary gingiva
- >3 units of pigmen- tation in the papillary gingiva without formation of a continuous ribbon
- More than equal to 1 short continuous ribbons of pigmentation
- One continuous ribbon including the entire area between the canines
Measured: 3 MONTHS
Patient-related outcome measures (PROMs) - POST-OPERATIVE PAIN PERCEPTION
post-operative pain perception/discomfort and esthetic satisfaction on a visual analog scale (VAS)
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.
Measured: 3 MONTHS
Patient-related outcome measures (PROMs) - ESTHETIC SATISFACTION
OVERALL ESTHETIC SATISFACTION WILL BE EVALUATED AS PER PATIENTS REPSONSE TO PREFERRED CHOICE OF TREATMENT - MICROSURGICAL OR DIODE LASER
Measured: 3 MONTHS
Secondary outcomes (7)
MELANOCYTE HISTOPATHOLOGIC COUNT (MHC)
EFFECT ON MHC
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).
Measured: 3 MONTHS
PERIODONTAL PARAMETER- PLAQUE INDEX (PI)
PLAQUE INDEX (PI)
" SCORE" " CRITERIA" 0 No plaque
- A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque could only be recognized by running a probe across the tooth surface area
- Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eyes.
- Abundance of soft matter on tooth and/or on the gingival margin.
Measured: 3 MONTHS
PERIODONTAL PARAMETER - GINGIVAL INDEX (GI)
GINGIVAL INDEX (GI)
Score Criteria 0 Absence of inflammation/normal gingiva.
- Mild inflammation, slight change in colour, slight oedema; no bleeding on probing within 30 seconds.
- Moderate inflammation; moderate glazing, redness, oedema, hypertrophy and bleeding on probing.
- Severe inflammation; marked redness and hypertrophy ulceration of gingival margin. Tendency to spontaneous bleeding.
Measured: 3 MONTHS
PERIODONTAL PARAMETER- BLEEDING ON PROBING (BOP)
BLEEDING ON PROBING (BOP)
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
Measured: 3 MONTHS
PERIODONTAL PARAMETER - PROBING POCKET DEPTH (PPD)
PROBING POCKET DEPTH (PPD)
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.
Measured: 3 MONTHS
PERIODONTAL PARAMETER - CLINICAL ATTACHMENT LEVEL (CAL)
CLINICAL ATTACHMENT LEVEL (CAL)
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
Measured: 3 MONTHS
PERIODONTAL PARAMETER - GINGIVAL RECESSION (GR)
GR 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.
Measured: 3 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion25 Sep 2023 (estimated)
- Study completion29 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival PigmentationStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AANCHAL SAHNI, BDS, Principal investigator, PGIDS ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930366
- Sponsor's protocol ID
- AANCHAL SAHNIPERIO3
- Status last verified
- Jun 2023
- First submitted
- 4 May 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Microsurgery vs Diode Laser Technique of Gingival Depigmentation on Pink Esthetics and Patient-related Outcomes: A Split-mouth Randomised Controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT05930366
- Acronym / sponsor ID
- AANCHAL SAHNIPERIO3
- Conditions
- Gingival Pigmentation, Melanosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 25 Sep 2023 (estimated)
- Study completion
- 29 Oct 2023 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 of these tissues. Over the decades many non-surgical as well as surgical techniques have been developed to remove the melanin induced hyper-pigmentation of gingival tissue with comparable efficacies. The surgical treatment modalities include use of scalpel, laser ablation, bur abrasion, electrocautery, cryosurgery, radio-surgery, free gingival grafts and acellular dermal matrix allograft etc. Diode lasers have frequently been used in a variety of soft tissue surgical procedures and have many advantages such as less pain, bleeding, scar formation and infection. Examined histologically, laser wounds have been resulted in less wound contracture or scarring, and ultimately improved healing. Depigmentation with lasers has become popular in recent times due to good results but requires sophisticated equipment and occupies a large space. Therefore the most practical gingival depigmentation procedure, both patient and operator wise, 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 diode laser technique.
Detailed description
AIM: To evaluate and compare the clinical, esthetic and patient-related outcomes of gingival depigmentation performed via Microsurgery vs Diode Laser 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 parameters13 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).
SETTING: Department of Periodontology and Oral Implantology, PGIDS, Rohtak, Haryana.
STUDY DESIGN: Split-mouth Comparative Randomised Controlled Clinical Study. 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 with a chief complaint of unpleasant appearance of gingival tissue will be recruited from the outpatient Department of Periodontology, PGIDS, Rohtak. 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 (Diode laser technique) group to each patient using a chit method.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gingival depigmentation using microsurgery | Active comparator | Procedure: Gingival depigmentation using microsurgerySurgical excision of hyper-pigmented gingival tissue using microsurgical blade (keratome 2.2) and magnification loupes under local anaesthesia. |
| Gingival Depigmentation using Diode Laser | Active comparator | Procedure: Gingival Depigmentation using Diode LaserAblation of hyper-pigmented gingival tissue using Diode Laser under local anaesthesia. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) Systemically healthy patients seeking treatment for gingival hyper-pigmentation.
Key exclusion criteria (10 listed)
- Gingival index (Leo and silliness 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gingival depigmentation using microsurgeryGINGIVAL DEPIGMENTATION USING MICROSURGICAL BLADE AND MAGNIFICATION LOUPES | Procedure or surgery | Gingival depigmentation using microsurgery |
| Gingival Depigmentation using Diode LaserGINGIVAL DEPIGMENTAION USING DIODE LASER | Procedure or surgery | Gingival Depigmentation using Diode Laser |
Primary outcome
CLINICAL PARAMETER- BLEEDING
Time frame: 3 MONTHS
Bleeding score classification in accordance to Ishi et al and Kawashima et al A: NONE B: SLIGHT C: MODERATE D: SEVERE
CLINICAL PARAMETER- REDNESS
Time frame: 3 MONTHS
Redness score classification in accordance to Ishi et al and Kawashima et al A: NONE B: SLIGHT C: MODERATE D: SEVERE
CLINICAL PARAMETERS- SWELLING
Time frame: 3 MONTHS
Swelling score classification in accordance to Ishi et al and Kawashima et al A: NONE B: SLIGHT C: MODERATE D: SEVERE
CLINICAL PARAMETER- WOUND HEALING
Time frame: 3 MONTHS
wound healing score classification in accordance to Ishi et al and Kawashima et al A: COMPLETE EPITHELIALIZATION B: INCOMPLETE OR PARTIAL EPITHELIALIZATION C: ULCER D: TRISSUE EFECT OR NECROSIS
CLINICAL PARAMETER- GINGIVAL COLOR
Time frame: 3 MONTHS
gingival color score classification in accordance to Ishi et al and Kawashima et al A: IMPROVEMENT B: SLIGHT IMPROVEMENT C: NO CHANGE D: DETERIORATION
DUMMETT ORAL PIGMENTATION INDEX (DOPI)
Time frame: 3 MONTHS
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)
HEDIN MELANIN INDEX (HMI)
Time frame: 3 MONTHS
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
Patient-related outcome measures (PROMs) - POST-OPERATIVE PAIN PERCEPTION
Time frame: 3 MONTHS
post-operative pain perception/discomfort and esthetic satisfaction on a visual analog scale (VAS) 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.
Patient-related outcome measures (PROMs) - ESTHETIC SATISFACTION
Time frame: 3 MONTHS
OVERALL ESTHETIC SATISFACTION WILL BE EVALUATED AS PER PATIENTS REPSONSE TO PREFERRED CHOICE OF TREATMENT - MICROSURGICAL OR DIODE LASER
7 secondary outcomes
MELANOCYTE HISTOPATHOLOGIC COUNT (MHC)
Time frame: 3 MONTHS
PERIODONTAL PARAMETER- PLAQUE INDEX (PI)
Time frame: 3 MONTHS
PERIODONTAL PARAMETER - GINGIVAL INDEX (GI)
Time frame: 3 MONTHS
PERIODONTAL PARAMETER- BLEEDING ON PROBING (BOP)
Time frame: 3 MONTHS
PERIODONTAL PARAMETER - PROBING POCKET DEPTH (PPD)
Time frame: 3 MONTHS
PERIODONTAL PARAMETER - CLINICAL ATTACHMENT LEVEL (CAL)
Time frame: 3 MONTHS
PERIODONTAL PARAMETER - GINGIVAL RECESSION (GR)
Time frame: 3 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AANCHAL SAHNI, BDS principal investigator
PGIDS ROHTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingival depigmentation using microsurgery and Gingival Depigmentation using Diode Laser in people with Gingival Pigmentation and Melanosis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RAJINDER KR SHARMA, MDS (9416258222, rksharmamds@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLINICAL PARAMETER- BLEEDING (time frame: 3 MONTHS). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.