| CTRI Number |
CTRI/2023/03/050706 [Registered on: 15/03/2023] Trial Registered Prospectively |
| Last Modified On: |
31/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment with ALVEOGYL, an alveolar dressing used in patients with a dry socket occurring after tooth extraction |
|
Scientific Title of Study
|
Prospective, Multicentre Clinical Trial Measuring the Impact of Treatment with
ALVEOGYL in Patients with Post-Extraction Dry Socket |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ALVE 2022-01, Version 1.0, Dated 08-Mar-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Srinath |
| Designation |
Professor |
| Affiliation |
MALLIGE HOSPITAL |
| Address |
Department of Oral and Facial Center
31/32, Crescent Rd, Madhava Nagar, Gandhi Nagar,
Bangalore
KARNATAKA
560001
India |
| Phone |
9844041408 |
| Fax |
|
| Email |
srinathdr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Srinath |
| Designation |
Professor |
| Affiliation |
MALLIGE HOSPITAL |
| Address |
Department of Oral and Facial Center
31/32, Crescent Rd, Madhava Nagar, Gandhi Nagar,
Bangalore
KARNATAKA
560001
India |
| Phone |
9844041408 |
| Fax |
|
| Email |
srinathdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K H Ramanjaneya |
| Designation |
Managing Director |
| Affiliation |
SMO Clinical Research (I) Pvt. Ltd |
| Address |
SMO Clinical Research (I) Pvt. Ltd.
261, 15th Main RMV Extension Sadhashiva Nagar
Bangalore
KARNATAKA
560080
India |
| Phone |
9845063779 |
| Fax |
|
| Email |
ram@smo-india.com |
|
|
Source of Monetary or Material Support
|
| SEPTODONT Pharmaceutical Company |
|
|
Primary Sponsor
|
| Name |
SEPTODONT |
| Address |
127 Boulevard Diderot - 75012 Paris, France |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SMO Clinical Research I Private Limited |
No. 84, 4th Cross, UAS Layout, Sanjaynagar, Bengaluru (Bangalore) Urban Karnataka (India) - 560094 |
|
|
Countries of Recruitment
|
India
France |
|
Sites of Study
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dinesh Shetty |
CAVALIER HOSPITAL |
410, 5th A Cross
Rd, HRBR
Layout 2nd
Block, HRBR
Layout, Kalyan
Nagar,
Bengaluru,
Karnataka
560043
Bangalore
KARNATAKA |
9739156065
dineshshettyb@gmail.com |
| Dr Bhaskar Salke |
DR. SALKE DENTAL & IMPLANT CENTRE |
Anjali Apartment,
Road below Om Hospital, Gokhalenagar,
Pune,
Maharashtra
411016
Pune
MAHARASHTRA |
9822616845
bhaskarsalke@gmail.com |
| Dr M Ashok Kumar |
ELEDENT International Digital Dentistry |
1st Floor Mig
160,Road No 1,
KPHB Colony,
Hyderabad -
500085
Hyderabad
TELANGANA |
9885522312
ashok.ms56@gmail.com |
| Dr N Srinath |
MALLIGE HOSPITAL |
31/32, Crescent
Rd, Madhava
Nagar, Gandhi
Nagar,
Bengaluru,
Karnataka
560001
Bangalore
KARNATAKA |
9844041408
srinathdr@gmail.com |
| Dr Dinesh Rohra |
MAYUR DENTAL CLINIC |
Swami Darshan
Complex, Shiv
Mandir Road,
Ambernath,
Maharashtra
421501
Mumbai
MAHARASHTRA |
9324712112
drdineshrohra@yahoo.co.in |
| Dr Mahantesha |
PERFECT DENTAL STUDIO |
43, 7th Main,
12th Cross Rd,
Mico Layout,
BTM 2nd Stage,
Bengaluru,
Karnataka
560076
Bangalore
KARNATAKA |
9844611562
mahanperio@gmail.com |
| Dr Manu B J |
SMILE DENTAL CARE |
Anand Nagar,
1st Main Road,
SBM Colony,
RBI Colony,
Ganganagar,
Bengaluru,
Karnataka
560021
Bangalore
KARNATAKA |
9844031233
smiledent007@yahoo.co.in |
| Dr Yokesh V Ratnam |
SMILE DENTAL CLINIC |
No 531/A, 17TH
CROSS, New
BEL Rd, RMV
2nd Stage,
Dollars Colony,
Devasandra Layout,
Bengaluru,
Karnataka
560094
Bangalore
KARNATAKA |
9448202199
yokeshvratnam@gmail.com |
| Dr Shardul Sontakke |
SMILE GALLERY DENTAL CARE CENTER |
2,Shakuntal,46/1
0 Law College
Road, Erandwana
Pune - 411004, Maharashtra, India
Pune
MAHARASHTRA |
9422356105
drshardulss@gmail.com |
| Dr Suhas S |
SRI SIDDHARTHA DENTAL COLLEGE |
B.H Road,
Agalkote
Tumkur
Karnataka
572107
Tumkur
KARNATAKA |
9113887673
suhassetty@gmail.com |
| Dr Muppirala Srikar |
SRI DENTAL MULTISPECIA LITY DENTAL HOSPITAL |
1st floor, Shivalasyam
complex, Telangana
Chowrasta, Beside BD Reddy
Convention, B.N.
Reddy Nagar, Hyderabad-500070
Hyderabad
TELANGANA |
8106789339
muppiralasrikar@gmail.com |
| Dr Preeti P Kambalyal |
THE DENTAL AVENUES |
Ashwini
Complex, #221,
9th Main Rd,
BEML Layout 3rd
Stage, RR
Nagar,
Bengaluru,
Karnataka
560098
Bangalore
KARNATAKA |
9602717070
drpreetipk@gmail.com |
| Dr Vishal Karkamkar |
VARDHAMAN DENTAL CARE |
Shop no. 10, S K
Pride CHS,
Beside SBI ATM
& Metropolis
Lab, Regency
Estate,
Dnyaneshwar
Nagar, East,
Dombivli,
Maharashtra
421203
Mumbai
MAHARASHTRA |
9819475083
dr.vishal.karkamkar@gmail.com |
| Dr DeepSagar T |
VRISA DENTAL |
SH19,
Hasthinapuram
Central, Laxmi
Narashima Puram Colony,
Hastinapuram,
Hyderabad,
Telangana
500074
Hyderabad
TELANGANA |
9885271792
deepsagar65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
| Deccan Independent Ethics Committee |
Approved |
| Deccan Independent Ethics Committee |
Approved |
| Deccan Independent Ethics Committee |
Approved |
| INDIRA IVF HOSPITAL ETHICS COMMITTEE |
Approved |
| INDIRA IVF HOSPITAL ETHICS COMMITTEE |
Approved |
| Institutional Ethics Committee SSMC, Tumkur |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M273||Alveolitis of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ALVEOGYL |
Alveogyl is a paste for alveolar surgical dressing after tooth extractions, with Penghawar fibers. The paste
promotes hemostasis by compression and protects
from superinfection (alveolar osteitis) with its barrier
effect.
when introduced into the socket, Alveogyl easily adheres to
the alveolus due to its fibrous consistency. Assisted
by the patient’s tongue movements, it gradually self
eliminates without any intervention by the practitioner as the normal healing of the wound takes place.
Small pellet (about 0.20 g) of paste will be placed gently into the prepared dental socket. Short term contact with the gingiva tissues and bones after placing it into the socket. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patient, adult or child
2. Positive diagnosis of dry socket occurring after the extraction
of a permanent tooth (mature or immature)
3. Signed informed consent |
|
| ExclusionCriteria |
| Details |
1. Spreading infection in the alveolar socket
2. Placement of Alveogyl done immediately after tooth extraction
3. Multiple post-extraction dry sockets
4. Patient treated with cervicofacial radiotherapy
5. Immunodeficiency related to any diseases or current treatments
6. Psychiatric patient
7. Patient with a history of hypersensitivity to one of the
components
8. Patient on post-extraction of deciduous teeth
9. Participation in another clinical investigation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Visual Analog Scale (VAS) at 7 days post-treatment |
8 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Painkiller intake: Analgesic use [Time Frame: at 3 days, 5 days
and 7 days post-treatment]
2. Healing: Evaluation of healing of the alveolar mucosa. [Time
Frame: at 7days post-treatment].
3. Local inflammation: Signs of inflammation around the gingival
mucosa (oedema, redness, sensitivity) [Time Frame: at 7 days
posttreatment].
4. Antiseptic effect: Clinical signs (e.g., gum pain, swollen gum
lining, fever, halitosis). [Time Frame: at 7 days post-treatment].
5. Haemostasis: presence or absence of bleeding [Time Frame:
after Alveogyl placement].
6. Safety: Complication rate [Time Frame: From Alveogyl
placement to 7days post-treatment] |
8 Days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/03/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
13/12/2022 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ALVE study is a clinical investigation assessing Alveogyl performance and safety in patients with post-extraction dry socket. The study will take place in India and in France where the study device is already marketed. Management of dry socket application protocol is at the discretion of the Investigator. Patients treated with the study device will be screened and eligible patients will be included in the study after obtaining their consent. The primary outcome will be pain assessed by Visual Analog Scale (VAS) for adults at 7 days post-treatment. VAS is a 10-point line from “no pain†(0 points) to “worst imaginable pain†(10 points). A corresponding scale will be used for children as appropriate. Additionally, patients will self-evaluate their pain level, their painkiller use, and the feeling of the Alveogyl (clove) taste on day 3 and day 5 at home. All data will be recorded in an electronic Case Report Form (eCRF) and monitored by the Sponsor’s designee. Self-evaluation by the patients will be recorded on a paper datasheet. |