CTRI Number |
CTRI/2023/03/050819 [Registered on: 17/03/2023] Trial Registered Prospectively |
Last Modified On: |
16/03/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To compare Early wound Healing and count of Periodontal pathogen following Gum surgery covered with silver membrane material under two different dressing material . |
Scientific Title of Study
|
Comparative analysis of Early wound Healing and Quantification of Circum-gingival Porphyromonas gingivalis following Periodontal Flap surgery covered with Nanocrystalline silver membrane under Visible light cure periodontal dressing(Barricaid) versus Non Eugenol Periodontal dressing(Coepak)- A Split mouth study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR DEEKSHA |
Designation |
I MDS |
Affiliation |
K.V.G Dental College and Hospital |
Address |
K.V.G Dental College and Hospital, Kurunjibhag, Sullia
Dakshina Kannada KARNATAKA 574327 India |
Phone |
9611026303 |
Fax |
|
Email |
deekshakulal1997@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR PRAKASH PAI G |
Designation |
PROFESSOR |
Affiliation |
K.V.G Dental College and Hospital |
Address |
K.V.G Dental College and Hospital, Kurunjibhag, Sullia
Dakshina Kannada KARNATAKA 574327 India |
Phone |
9845156405 |
Fax |
|
Email |
prakashpaipai2014@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR DEEKSHA |
Designation |
I MDS |
Affiliation |
K.V.G Dental College and Hospital |
Address |
K.V.G Dental College and Hospital, Kurunjibhag, Sullia
KARNATAKA 574327 India |
Phone |
9611026303 |
Fax |
|
Email |
deekshakulal1997@gmail.com |
|
Source of Monetary or Material Support
|
KVG dental college and hospital , department of perioodntology , kurunjibhag , sullia , Dakshina kannada district , karnataka , india |
|
Primary Sponsor
|
Name |
Dr Deeksha |
Address |
Ist year Post Graduate, Department of Periodontology, K.V.G Dental college and Hospital, Kurunjibhag, Sullia, Dakshina Kannada, Karnataka, India |
Type of Sponsor |
Other [SELF ] |
|
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 DEEKSHA |
KVG dental college and hospital |
Room no : 11 , department of periodontology , KVG dental college and hospital , Kurunjibag , Sullia , Dakshina kannada district Dakshina Kannada KARNATAKA |
9611026303
deekshakulal1997@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE |
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 |
Intervention |
PERIODONTAL FLAP SURGERY AND PLACEMENT OF BARRICAID PACK UNDER NANOCRYSTALLINE SILVER MEMBRANE . |
PERIODONTAL FLAP SURGERY AND PLACEMENT OF BARRICAID PACK UNDER NANOCRYSTALLINE SILVER MEMBRANE WILL BE DONE FOR 7 DAYS . |
Comparator Agent |
PERIODONTAL FLAP SURGERY AND PLACEMENT OF COE - PAC UNDER NANOCRYSTALLINE SILVER MEMBRANE |
PERIODONTAL FLAP SURGERY AND PLACEMENT OF COE - PAC UNDER NANOCRYSTALLINE SILVER MEMBRANE WILL BE DONE FOR 7 DAYS . |
|
Inclusion Criteria
|
Age From |
35.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1.Patients aged 35 to 70 years old were chosen.
2.Patients who do not have any systemic illness.
3.Patients with periodontal pocket of >5mm depth.
4.Patients with untreated periodontal disease.
5.People who are receiving periodontal flap surgery. |
|
ExclusionCriteria |
Details |
1.Medically compromised patients.
2.Lactating or pregnant women.
3.Mentally and physically challenged subjects.
4.Patients allergic to silver and any of the periodontal dressing materials.
5.Patients with smoking habit.
6.Subjects having tobacco habits in any form and alcoholics. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
EARLY WOUND HEALING FOR PERIODONTAL FLAP SURGERY USING TWO DIFFERENT PERIOODNTAL PACK |
7 DAYS FOLLOWING FLAP SURGERY |
|
Secondary Outcome
|
Outcome |
TimePoints |
QUANTIFICATION OF CIRCUM-GINGIVAL PORPHYROMONAS GINGIVALIS FOLLOWING FLAP SURGERY |
7 DAYS FOLLOWING FLAP SURGERY |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 3/ Phase 4 |
Date of First Enrollment (India)
|
03/04/2023 |
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
|
NOT YET PUBLISHED |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
All the patients will be selected from the out patients section of The Department of Periodontology, KVG Dental College and Hospital, Sullia. Fifteen Subjects diagnosed with periodontitis undergoing periodontal flap surgeries will be selected for the study.Sextants are selected randomly and divided into two part . Each part is selected randomly to cover with Nanocrystalline silver membrane under Barricaid® and Coe-pakTM dressing materials. clinical parameters will be recorded for each patient after 7 days of surgery and circum-gingival plaque sample will be obtained from gingival sulcus with the help of curette and kept in Tris EDTA buffer which can be stored for 72 hours at the temperature of 4 ºC .Those samples will be assessed for Porphyromonas gingivalis count using real time PCR. Following parameters are measured

(1)Inflammation papillary marginal attachment index(Maury Massler and Schour) (2)Quigley hein plaque index (3) Healing index by Landry et al. Statistical analysis will be performed to compare the changes of clinical parameter between Barricaid® and Coe-pakTM dressing materials when placed over Nanocrystalline silver membrane. Prior to the surgical operation, all participants will have an examination and treatment planning appointment, and will receive suitable oral hygiene instructions as well as an initial scaling and root planing treatment. Flap surgery will be carried out under standard protocol. Sextant will be selected and divided into two parts. Each part will be selected randomly to cover with Barricaid® or Coe-pakTM along with nanocrystalline silver membrane. After 7th day of surgery, clinical parameters will be checked and circum-gingival plaque sample will be collected for Porphyromonas gingivalis count. Surgical procedure Subjects that meet the inclusion criteria will be chosen for flap surgery. Preoperatively patients will be given chlorhexidine mouthwash 0.12% (Perioguard) for mouth rinsing, before giving local anesthesia. All aseptic precautions and standard protocol will be followed during flap surgery. All the patients will be treated using 2% lignocaine hydrochloride with adrenaline in 1:80000 concentrations (Lignox 2% -A). Incision will be given with B.P. blade no. 15. on the buccal and lingual surface and B.P. blade no 12 on the interdental region. Following reflection and debridement, the surgical site will be irrigated and flap approximation will begin using 3-0 silk sutures and covered with Acticoat TM under Barricaid® or Coe-pakTM dressing materials. The photocured dressing will be dispensed at the juncture of the cervical one third of the teeth and the margin of the surgical site on the facial and lingual aspect. It is then exposed to visible light curing unit for 10 seconds per site per tooth until the entire dressing coverage was checked prior to dismissing the patient. At the other surgical site, after drying with gauze Coe-pakTM will be applied.
Post-operative instructions will be given. Antibiotics and analgesics would be administered. The dressing materials will be removed on the seventh day. All clinical parameters will be monitored, and a circum-gingival plaque specimen will be obtained after the seventh day and stored in transport media for real-time PCR. Postoperative recall Subjects will be reviewed after 7th day for evaluating clinical parameter and circum-gingival plaque sample will be collected after 7th day of surgery. |