| 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
|
|
|
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
|
|
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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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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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