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CTRI Number  CTRI/2016/02/006639 [Registered on: 15/02/2016] Trial Registered Retrospectively
Last Modified On: 04/05/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two different surgical techniques for the treatment of gum diseases 
Scientific Title of Study   Comparison of single flap approach to double flap approach for effective management of intraosseous defects in chronic periodontitis –A randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anju P 
Designation  Junior Resident (MDS -Periodontology) 
Affiliation  Government Dental College,Kottayam 
Address  Department of Periodontics (Room no.503), Govt Dental College, Gandhinagar p.o.

Kottayam
KERALA
686008
India 
Phone  9496346079  
Fax    
Email  dranjuputhumana@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shibu Godfrey Pereira 
Designation  Professor 
Affiliation  Government Dental College,Kottayam 
Address  Department of Periodontics, Govt Dental College, Gandhinagar p.o.

Kottayam
KERALA
686008
India 
Phone  9447769184  
Fax    
Email  drgodfreydct@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anju P 
Designation  Junior Resident (MDS -Periodontology) 
Affiliation  Government Dental College,Kottayam 
Address  Department of Periodontics (Room no.503), Govt Dental College, Gandhinagar p.o.

Kottayam
KERALA
686008
India 
Phone  9496346079  
Fax    
Email  dranjuputhumana@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontics, Government Dental College, Gandhinagar p.o. Kottayam Pin - 686008 
 
Primary Sponsor  
Name  Dr Anju P 
Address  Junior Resident, Department of Periodontics, Government Dental College, Gandhinagar p.o. Kottayam pin - 686008 
Type of Sponsor  Other [Principal Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Anju P  Department of Periodontics, Government Dental College, kottayam  Department of Periodontics Room no. 503 Government Dental College Gandhinagar p.o Kottayam Pin 686008
Kottayam
KERALA 
9496346079

dranjuputhumana@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee(IEC)/ Institutional review board(IRB)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Double Flap Approach  Envelope flap without vertical releasing incisions is performed at both buccal and oral aspects splitting the papilla at the intrabony defect. Then, periosteal elevator is used to elevate the flaps and defect debrided with hand instruments. Flap closure is done, sutures are placed and surgical site is covered with periodontal dressing for one week 
Intervention  Single Flap Approach  Buccal envelope flap without vertical releasing incisions with papilla preservation is done at the intrabony defect. Then, periosteal elevator is used to elevate the flaps and defect debrided with hand instruments. Flap closure is done, sutures are placed and surgical site is covered with periodontal dressing for one week 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Chronic periodontitis patients aged 35 yrs or more
2. Interproximal intraosseous periodontal defect with pocket depth 5 mm and radiographic evidence of bone loss 3mm or more with no extension of the defect on the lingual or palatal side as assessed by preoperative bone sounding. 
 
ExclusionCriteria 
Details  1. Third molars , Class III mobility & furcation involvement
2. Inadequate endodontic treatment and/or restoration
3. Systemic diseases or conditions that contraindicate periodontal surgery
4. History of periodontal surgery or antibiotic usage within previous six months
5. Not willing to sign an informed consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Gain in clinical attachment level calculated as the distance from the CEJ to the base of the
gingival sulcus/periodontal pocket 
at 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Probing depth reduction(PDR): Probing pocket depth is distance from the gingival margin to the gingival sulcus which is measured by UNC-15 graduated periodontal probe
2. Gingival recession reduction(GRR): Gingival recession is measured from the CEJ to the gingival margin
3. Change in radiographic bone density as assessed by digital radiographs using imaging software. 
1. Probing depth reduction(PDR): Probing pocket depth is distance from the gingival margin to the gingival sulcus which is measured by UNC-15 graduated periodontal probe at 3 months and 6 months
2. Gingival recession reduction(GRR): Gingival recession is measured from the CEJ to the gingival margin at 3 months and 6 months
3. Change in radiographic bone density as assessed by digital radiographs using imaging software at 6 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   22/01/2014 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
Conventional surgical approach ie, double papilla approach for management of intraosseous defects includes raising of flaps on both buccal and lingual/palatal side after splitting the papilla with sulcular incision. This may cause unwanted interproximal bone exposure in cases of lesions confined to either buccal/lingual aspect which can eventually leads to impairment of interdental papilla and bone loss. To overcome this papilla preservation techniques were introduced.1 Narrow intrabony defects resulted in complete clinical repair even without regenerative therapy.Clinical outcomes of open flap debridement was as effective as open flap debridement and grafts in some studies of intrabony defect management.A novel, simplified, minimally-invasive surgical approach to access intraosseous periodontal defects with limited mucoperiosteal flap elevation is Single-flap approach(SFA) which allows access from either buccal or lingual aspect depending on  extension of the lesion leaving interproximal supracrestal gingival tissues intact. Radiographic density was not assessed in the study by Trombelli et al which will be assessed in this study as secondary outcome.Patients fulfilling inclusion criteria are subjected to full mouth scaling and root planning. Reevaluated at 6th week and clinical parameters recorded at that time as baseline records.Trained examiner other than the principal investigator assesses the clinical parameters. The examiner will be masked to treatment allocations for the entire duration of the study. All subjects shall be required to answer a detailed questionnaire including demographic information (name, Age, sex, Address), medical and dental history. Clinical parameters, recorded by a single, trained examiner other than the investigator at six aspects per tooth: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual are gain in clinical attachment level (gCAL), probing depth reduction(PDR), and gingival recession (GRR) reduction using UNC-15 probe.Surgical Protocol: In SFA group: Buccal envelope flap without vertical releasing incisions with papilla preservation is done. In DFA group: Envelope flap without vertical releasing incisions is performed at both buccal and oral aspects splitting the papilla. In both groups, periosteal elevator is used to elevate the flaps and defect debrided with hand instruments. Flap closure is done, sutures are placed and surgical site is covered with periodontal dressing for one week. Patients are informed to report if any untoward complications develop immediately. Post surgical evaluation is done at 3 months and 6 months.


RESULTS:

There were no statistically significant difference in clinical and radiographic parameters between two groups tested at baseline (P value > 0.05). Hence both groups were comparable at baseline. In SFA group, on comparing pre-surgical and postsurgical PPD and CAL at 3 months and 6 months, there was statistically significant mean PPD reduction and CAL gain (P value <0.05).The mean reduction in probing pocket depth at 3 months was 3.091 ± 0.735mm and at 6 months was 3.636 ± 0.595mm (P value <0.001). The mean gain in clinical attachment level was 3.136 ± 0 .839mm at 3 months and 3.727 ± 0.876mmat 6 months(P value <0.001).The mean reduction in gingival recession in 3 months and from baseline to 6 months was 0.0 ± 0.447 which was not statistically significant (P value = 1.00). In DFA group, on comparing pre-surgical and postsurgical PPD and CAL at 3 months and 6 months, there was statistically significant mean PPD reduction and CAL gain (P value <0.05). The mean reduction in probing pocket depth at 3 months was 3.182 ± .603mm and at 6months was 3.545 ± 0.522mm (P value <0.001). The mean gain in clinical attachment level was 2.909 ± 0.831mm at 3 months and 3.273 ± 0.905mm at 6 months(P value <0.001).The mean increase in gingival recession in 3 months and from baseline to 6 months was 0.273 ± 0.647mm which shows no statistically significant difference. (P value = 0.192). In SFA group radiographic density showed a statistically significant difference at 6 months (P value <0.05) while comparing pre-surgical and post-surgical densitometric analysis. The mean change in radiographic density was 15.333 ± 16.299 in 6 months. In DFA group radiographic density showed a statistically significant difference at 6 months (P value <0.05) while comparing pre-surgical and post-surgical densitometric analysis. The mean change in radiographic density was 9.303 ± 20.602 in 6 months. On comparing change in probing pocket depth in first 3 months between two groups, DFA showed a higher reduction in probing pocket depth by 0.0901mm (P value = .755) and higher post - surgical gingival recession of 0.273 in DFA group. (P value = .264). Clinical attachment gain was higher in SFA by 0.227mm. But these changes were not statistically significant (P value >0.05). On comparing change in clinical parameters 6 months post surgically between two groups, SFA showed a slight higher reduction in probing pocket depth by 0.091mm and slight higher clinical attachment gain of 0.455mm. DFA showed slight higher post - surgical gingival recession of 0.273mm. These changes were not statistically significant (P value > 0.05). The change in radiographic density when compared between groups was also insignificant (P value > 0.05).

 
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