| CTRI Number |
CTRI/2018/03/012621 [Registered on: 16/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The comparison of three different techniques for the treatment of gum and bone diseases of behind teeth in the mouth |
|
Scientific Title of Study
|
A comparative clinical and radiographic evaluation of bidirectionally positioned flap and GTR membrane with bioactive glass in the treatment of mandibular Class II furcation defects-A randomized controltrial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 15115 (14-11-2015) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of dental sciences |
| Address |
Department of Periodontology
Manipal College of dental sciences
manipal acadey of higher education
Light house hill road,
Mangalore
-
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09591328506 |
| Fax |
- |
| Email |
dr.shikha19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashita Uppoor |
| Designation |
Associate Dean |
| Affiliation |
Manipal College of dental sciences, Manipal Academy of higher education (MAHE) |
| Address |
Room 4, Department of Periodontology
Manipal College of dental sciences
manipal acadey of higher education
Light house hill road,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9686468089 |
| Fax |
- |
| Email |
ashita.uppoor@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shikha |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of dental sciences |
| Address |
Department of Periodontology
Manipal College of dental sciences
manipal acadey of higher education
Light house hill road,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09591328506 |
| Fax |
- |
| Email |
dr.shikha19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology,
Manipal College of dental sciences,Manipal academy of higher education, Light house hill road, Hampankatta, Mangalore, Karnataka |
|
|
Primary Sponsor
|
| Name |
Manipal college of dental sciences Manipal Academy of Higher Education MAHE Mangalore |
| Address |
department of Periodontology
Manipal college of dental sciences ,Manipal Academy of Higher Education MAHE, Light house hill road, Hampankatta, mangalore, Karnataka |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Shikha |
Manipal College of dental sciences, Mangalore |
Department of Periodontology, Manipal College of dental sciences, Manipal academy of higher education,
Light house hill road,
mangalore
Karnataka
Dakshina Kannada
KARNATAKA |
9591328506
-
dr.shikha19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Manipal college of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Mandibular molars with Class II buccal furcation defects (Hamp et.al. 1975), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A : Bidirectionally positioned flap in combination with bioactive glass |
Under local anaesthesia and all aseptic conditions with number 15c blade a partial thickness horizontal incision was given 2mm apical to the gingival margin. Mesial and distal full thickness vertical releasing incision were given and a trapezoidal partial thickness flap was reflected. Then the underlying periosteal pedicle flap was reflected upto the mucogingival junction with mesial and distal vertical releasing incisions and a horizontal releasing incision was given at its base. The exposed furcation defect and the adjacent bone was thoroughly debrided and irrigated using betadine mouthwash and exposed roots were thoroughly planed. Bioactive glass particulate graft was then packed into the furcation defect with the help of a plastic instrument and condensed in place. Care was taken that the defects were adequately filled and not under or over filled. Then the periosteal pedicle flap was coronally advanced, overlying the packed furcation defect completely and sutured using 4-0 resorbable suture using one sling suturing technique. The outer trapezoidal partial thickness flap was sutured at the same position, without any tension using 5-0 non-resorbable silk suture using simple interrupted suturing technique for the vertical releasing incisions and the first horizontal incisions. Periodontal dressing was then placed to cover the surgical site completely. |
| Intervention |
Group B : Open flap debridement in combination with GTR membrane and bioactive glass |
Under local anaesthesia and all aseptic conditions with no. 12 blade a sulcular incisions was given and a full thickness (mucoperiosteal) flap was reflected retaining sufficient tissue to attain primary closure. The exposed furcation defect and the adjacent bone was thoroughly debrided and irrigated using betadine mouthwash and exposed roots were thoroughly planed. Bioactive glass particulate graft was then packed into the furcation defect with the help of a plastic instrument and condensed in place. Care was taken that the defects were adequately filled and not under or over filled. Then a correctly contoured bioabsorbable GTR membrane was used to cover the defect and it is stabilized with a sling suture. The mucoperiosteal flap was then adapted and sutured in position with 4-0 resorbable suture. Periodontal dressing was then placed to cover the surgical site completely. |
| Comparator Agent |
Group C : Open flap debridement |
Under local anaesthesia and all aseptic conditions with no. 12 blade sulcular incisions was given and a full thickness (mucoperiosteal) flap was reflected retaining sufficient tissue to attain primary closure. The exposed furcation defect and the adjacent bone was thoroughly debrided and irrigated using betadine mouthwash and exposed roots were thoroughly planed. The mucoperiosteal flap was then adapted and sutured in position with 5-0 non-resorbable silk suture. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients age 20 and more irrespective of gender.
2.Mandibular molars with Class II buccal furcation defects (Hamp et.al. 1975)34
3.Vertical Clinical attachment loss of ≥4mm after initial therapy.
4.Adequate gingival biotype of ≥1mm.
|
|
| ExclusionCriteria |
| Details |
1.Tobacco consumption of any type.
2.Immunocompromised individuals.
3.Patients with compromised systemic health and contraindicated for periodontal surgery.
4.History of previous periodontal surgery performed at the site of interest in the past 24 months.
5.Patients undergoing orthodontic treatment.
6.Pregnant or lactating females.
7.Third molars with furcation involvement.
8.Untreated non-vital teeth.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
i.Vertical probing pocket depth (VPPD)
ii.Horizontal probing depth (HPD)
iii.Probing Clinical attachment level (PCAL) |
Baseline and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Gingival Recession (GR)
ii. Radiographic furcation depth (RFD) |
Baseline and six months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2015 |
| Date of Study Completion (India) |
15/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
The study evaluated the treatment outcomes clinically and radiographically of bidirectionally positioned flap (BPF) technique in combination with bioactive glass to open flap debridement with bioresorbable collagen membrane in combination with bioactive glass and open flap debridement alone for the treatment of mandibular molar class II furcation defects. A total of 24 class II furcation defects in 24 patients with mean age of 50.75 were enrolled after satisfying the inclusion and exclusion criteria. Every patient signed the informed consent form. The baseline and six months postoperative treatment parameters were compared. Within the limiations , it was concluded that, appropriate case selection and treatment planning is the key to achieving the best results in the treatment of class II mandibular molar furcation defects. The BPF technique in combination with a bone graft substitute and bioresorbable membrane in combination with bone graft substitue showed better results in comparision to open flap debridement. The BPF technique in combination with a bone graft substitue may show comparable treatment outcomes with the bioresorbable membrane in combination with bone graft substitute. Future studies are required with longer followups and sample size to make further definitive conclusions in using BPF surgery in combination therapy for molar class II furcation defects. |