| CTRI Number |
CTRI/2025/09/094323 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Regeneration of the gums between front teeth using blood derived products and soft tissue laser. |
|
Scientific Title of Study
|
Comparative evaluation of liquid phase concentrated growth factors with and without haemolaser therapy in anterior papillary reconstruction-a randomized clinical trial |
| Trial Acronym |
LPCGF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maturu Sai Sruthi |
| Designation |
Post Graduate Student |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room no.5,2nd floor,
Department Of Periodontology ,Narayana Dental College and Hospital, Chintareddy palem, SPSR Nellore , Andhra Pradesh.
Nellore ANDHRA PRADESH 524003 India |
| Phone |
6300066984 |
| Fax |
|
| Email |
maturusaisruthi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gunupati Sumanth |
| Designation |
Professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room no.5,2nd floor,
Department Of Periodontology ,Narayana Dental College and Hospital, Chintareddy palem, SPSR Nellore, Andhra Pradesh
Nellore ANDHRA PRADESH 524003 India |
| Phone |
8885393855 |
| Fax |
|
| Email |
sumant2930@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Gunupati Sumanth |
| Designation |
Professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room no.5,2nd floor,
Department Of Periodontology ,Narayana Dental College and Hospital, Chintareddy palem, SPSR Nellore, Andhra Pradesh
Nellore ANDHRA PRADESH 524003 India |
| Phone |
8885393855 |
| Fax |
|
| Email |
sumant2930@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Maturu Sai Sruthi |
| Address |
Room no.5, 2nd floor,
Department Of Periodontology,
Narayana Dental College and Hospital,
Chintareddy palem,
SPS Nellore District
Pin code: 524003 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Maturu Sai Sruthi |
Narayana dental college and hospital |
Room no 5,2 nd floor, department of periodontology, narayana dental college and hospital, chinthareddypalem, sps nellore Nellore ANDHRA PRADESH |
6300066984
maturusaisruthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe NDCHe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
liquid phase concentrated
growth factors |
Injectable liquid phase concentrated
growth factors and haemolaser therapy will be done where
laser will be passed without activation of the diode laser tip. |
| Intervention |
liquid phase concentrated
growth factors with haemolaser therapy |
injectable liquid phase concentrated
growth factors with haemolaser therapy with activated laser
tip.
This procedure is carried out at baseline and after a week.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with class I, class II, or class
III [Nordland and Tarnow classification]
anterior interdental papillary loss.
2. Non-smoker participants.
3. Participants who can maintain good oral
hygiene.
4. male and female participants with age
group of 18-50 years.
5.The participants who have a healthy
periodontal state |
|
| ExclusionCriteria |
| Details |
1.Participants with any systemic diseases.
2. Consumption of drugs causing gingival
hyperplasia.
3. Participants with periodontal pocket and
malocclusion.
4.Pregnant and lactating women.
5. Participants who have coagulopathies.
6.Participants who are undergoing
orthodontic treatment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anterior Interdental papillary gain. |
Baseline, 4 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gingival index
Bleeding index
Pain score-Visual Analogue Scale |
Gingival index, Bleeding index-Baseline, 4 weeks, 24 weeks
Visual Analogue Scale- Baseline, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
10/12/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Systemically healthy Participants with anterior interdental papillary loss will be selected from outpatient Department of Periodontology, Narayana Dental College and Hospital, depending upon the inclusion criteria. After obtaining written informed consent, the selected participants will be subjected to scaling and root planing, oral hygiene instructions will be advised .The participants will be recalled after 4 weeks, and Anterior Papillary loss measurements will be taken using a UNC -15 probe and digital photographs. The participants will be selected and randomly assigned by computer generated method into two groups, Group 1 will receive injectable liquid phase concentrated growth factors and haemolaser therapy will be done where laser will be passed without activation of the diode laser tip. Group 2 will receive injectable liquid phase concentrated growth factors with haemolaser therapy with activated laser tip. Each papillary defect will be measured as a triangle with the height measured from the interdental contact point to the tip of papilla. Base will be measured as the distance between the proximal surfaces of the adjacent tooth surfaces at the tip of papilla. 10 ml of blood sample will be collected from antecubital region and transferred into the plain plastic tubes. The collected blood will be centrifuged, as per the sacco protocol and Liquid-phase concentrated growth factors are obtained by this method will be injected using an insulin syringe into the connective tissue layer at the base of the gingival papilla for both treatment groups after giving local anaesthesia at the recipient site. Haemolaser therapy will be achieved through Photo Biomodulation. Pocket marker is used to mark 4 bleeding points on the gingiva between two anterior teeth, that is at (coronal third of papilla, apical third of the papilla, mesial and distal surfaces of the papilla). Later bleeding will be provoked by using curette inside the sulcus by applying pressure on junctional epithelium and supra crestal connective tissue. Photo biomodulation therapy will be applied with diode Laser( by following laser safety protocol like using protective eye shields )in two stages: First Stage: Photo Biomodulation Therapy (Pre-Bleeding) where in the fiber tip of diode laser will be inserted approximately 3-4 mm into the interdental papilla (at the base of the papilla). The laser will be applied to the designated spots around the gingiva. Second Stage: Photo Biomodulation Therapy (Post Bleeding). Again, the fiber tip will be inserted into the interdental papilla at the base, and laser treatment will be applied to the previously marked areas of the gingiva. Haemolaser therapy will be done on baseline and after1 week in both groups. |