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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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
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.

 
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