| CTRI Number |
CTRI/2025/11/097879 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How Laser Treatment Helps Improve Gum Thickness Around Dental Implants Around Implants |
|
Scientific Title of Study
|
EFFECT OF LASER PATTERNED MICROCOAGULATION
TREATMENT IN GINGIVAL BIOTYPE CONVERSION AROUND
IMPLANTS. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rathod Srikanth |
| Designation |
Post Graduate Student in Periodontics |
| Affiliation |
Svs institute of dental sciences |
| Address |
Svs institute of dental sciences
Department of periodontics room no 05
Yenugonda mahabubnagar
Mahbubnagar
TELANGANA
509001
India |
| Phone |
9542334925 |
| Fax |
|
| Email |
drrathodsrikanth25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. V. SANTOSH KUMAR GOUD, MDS |
| Designation |
Professor |
| Affiliation |
Svs institute of dental sciences |
| Address |
Svs institute of dental sciences
room no:05, Department of periodontics
Yenugonda mahabubnagar
Mahbubnagar
TELANGANA
509001
India |
| Phone |
9885172721 |
| Fax |
|
| Email |
vallabhdassantosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. V. SANTOSH KUMAR GOUD, MDS |
| Designation |
Professor |
| Affiliation |
Svs institute of dental sciences |
| Address |
Svs institute of dental sciences
Department of periodontics, room no 05
Yenugonda mahabubnagar
Mahbubnagar
TELANGANA
509001
India |
| Phone |
9885172721 |
| Fax |
|
| Email |
vallabhdassantosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian society of periodontics- ISP |
|
|
Primary Sponsor
|
| Name |
Indian society of periodontology Grants committeem |
| Address |
Dr. Ashish Jain Honorary Secretary ISP 721, phase 3b-1 Mohali 160059 India
secretaryispindia@gmail.com |
| Type of Sponsor |
Other [Indian society of periodontology -Grants committee 2025] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr R Viswa Chandra |
svs institute of dental sciences
Mahabubnagar, telangana
509001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rathod Srikanth |
Svs institute of dental sciences |
SVS INSTITUTE OF DENTAL SCIENCES
Department of periodontics, room no:05
APPANAPALLY MAHABUBNAGAR TELANAGANA PINCODE:509001
Mahbubnagar
TELANGANA |
9542334925
drrathodsrikanth25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Svs institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laser-Patterned Micro coagulation Treatment for Gingival Biotype Conversion Around Dental Implants |
A sample size of twelve participants per group, making a total of twenty four participants, was calculated to evaluate the gingival biotype around implants with laser patterned micro coagulation between the mean periods of three months and six months. The calculation was based on a confidence level of ninety five percent and a desired power of eighty percent.
For the intervention, a diode laser with a wavelength of nine hundred and forty nanometers and a tip diameter of two hundred micrometers will be applied at the test site in a pulsed contact mode. |
| Comparator Agent |
Micro needling-Assisted Gingival Biotype Modification Around Dental Implants
by
Dr. Rathod Srikanth |
In the control group, local anesthesia is given at the selected site. Microneedling is performed using a Dr Pen Ultima A6 device on the target area. The device is inserted straight into the soft tissue until it touches the underlying bone. This step is repeated several times to complete microneedling on the keratinized gingiva. Small pinpoint bleeding will be seen as part of the procedure.
The outcomes include the assessment of gingival thickness using transgingival probing, the assessment of the width of keratinized tissue measured from the mucogingival junction to the free gingival margin using a UNC fifteen probe at baseline and after the procedure, the assessment of clinical attachment level using a UNC fifteen probe, and the assessment of bleeding on probing using the modified sulcus bleeding index described by Mombelli and colleagues.
The secondary outcomes include the assessment of the peri implant plaque index described by Mombelli and colleagues and the assessment of the modified gingival index described by Lobene and colleagues. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients with greater than 18 years of age.
2.Patient with gingival phenotype thickness less than 1.5mm.
3.Patient having inadequate width of attached gingiva. |
|
| ExclusionCriteria |
| Details |
1.Medically compromised patients.
2.Pregnant and lactating women.
3.Patient undergoing orthodontic treatment.
4.Patient having preexisting mucogingival deformities.
5.Patient taking any medication that causes gingival enlargement. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assessment of gingival thickness using transgingival probing.
2.Assessment of width of keratinized tissue (measure from the mucogingival junction to free gingival margin )
using UNC-15 probe at baseline and post operatively.
3.Assessment of clinical attachment level by using UNC-15.
4.Assessment of bleeding on probing ( modified sulcus bleeding index) - according to Mombelli et. al |
2.Assessment of width of keratinized tissue (measure from the mucogingival junction to free gingival margin )
using UNC-15 probe at baseline and post operatively, at baseline 3 months and 6 months .
3.Assessment of clinical attachment level by using UNC-15, at baseline 3 months and 6 months.
4.Assessment of bleeding on probing ( modified sulcus bleeding index) - according to Mombelli et. al, at baseline 3 months, 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assessment of peri implant plaque index according to Mombelli et.al, at baseline 3 months, 6 months.
2.Assessment of modified gingival index - according to Lobene et.al, at baseline 3 months & 6 months. |
02
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Brief Summary
Rationale and Gaps in Existing Knowledge: Various surgical techniques such as connective tissue grafts and enamel matrix derivatives have been used for phenotype modification to increase soft tissue thickness and improve treatment outcomes. However, these procedures require high surgical skill and may result in reduced patient compliance. To overcome these limitations, a minimally invasive microsurgical approach using Laser Patterned Micro Coagulation (LPM) has been developed to enhance gingival tissue quality. LPM helps in converting a thin gingival biotype into a thicker one, which is especially important in implant dentistry.
Novelty: LPM may have potential applications in the management of gingival recession and stimulation of growth and regeneration of interdental and inter-implant papillae.
Objectives: The aim of the study is to modify the gingival biotype around implants by using laser patterned micro coagulation.
Methods: A total of 24 participants will be included, with 12 in each group. The study will evaluate gingival biotype changes around implants at 3 and 6 months with a 95 percent confidence interval and 80 percent power. At the test site, a diode laser with wavelength 940 nm and 200 micrometer tip will be applied in pulsed contact mode. In the control group, local anesthesia will be administered and microneedling will be performed using Dr Pen Ultima A6 applied perpendicularly to the soft tissue until bone contact is achieved.
Outcomes: Primary outcomes include assessment of gingival thickness by transgingival probing, width of keratinized tissue, clinical attachment level, and bleeding on probing according to Mombelli et al. Secondary outcomes include peri-implant plaque index and modified gingival index according to Lobene et al. |