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CTRI Number  CTRI/2024/12/077794 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 23/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A six month comparison of the clinical and radiographic changes in periodontium after the surgical management of class II furcation defects when using a modified periodontal sling suture procedure versus conventional sling suture procedure  
Scientific Title of Study   Clinico-Radiographic Comparison of Cross Sling Suture with Conventional Sling Suture in the Surgical Management of Class II Furcation Defects – A Randomized Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1315-9394  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shraddha Gupta 
Designation  PG Student, Department of Periodontology and Oral Implantology 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Room No 5; Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140

Dehradun
UTTARANCHAL
248140
India 
Phone  7042253751  
Fax    
Email  periopg.udmri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aaron F Gomes 
Designation  PG Guide, Professor and Head, Department of Periodontology and Oral Implantology 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140

Dehradun
UTTARANCHAL
248140
India 
Phone  09860597402  
Fax    
Email  aarongomes@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aaron F Gomes 
Designation  PG Guide, Professor and Head, Department of Periodontology and Oral Implantology 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140


UTTARANCHAL
248140
India 
Phone  09860597402  
Fax    
Email  aarongomes@hotmail.com  
 
Source of Monetary or Material Support  
Dr Aaron F Gomes, Dept of Periodontology and Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, Dehradun, Uttarakhand. 248140 
 
Primary Sponsor  
Name  Aaron F Gomes 
Address  Uttaranchal Dental and Medical Research Institute, Mazri Grant, Dehradun, Uttarakhand, 248140 
Type of Sponsor  Other [Self] 
 
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 AARON F GOMES  Uttaranchal Dental and Medical Research Institute   Room No 5, Dept of Periodontology and Oral Implantology, Uttaranchal Dental and Medica Research Institute, Majri Grant, Haridwar road, Dehradun
Dehradun
UTTARANCHAL 		 09860597402

aarongomes@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Uttaranchal Dental and Medical Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Sling Suture for Class II Furcation defects  The periodontal flap surgical procedure in will be performed under local anaesthesia so as to treat class II furcation defects with bone graft and membrane. A crevicular incision will be given on the buccal or lingual aspect at the defect site as per the presence of entry of the defect, extending one tooth adjacent to the involved tooth, both distally and mesially. A full thickness muco-periosteal flap will then be elevated. The granulation tissue will be removed in the furcation defect and a thorough debridement will be carried out with Gracey curettes so as to obtain a smooth hard surface. Any adherent granulation tissue will be trimmed from the flap. A gentle approximation of the flap will be done before the insertion of the Bone graft material, and GTR membrane, so as to determine the coronal extent of GTR membrane needed. After irrigation at the defect with normal saline, bone graft material will be dispensed into the bone well and will be carried to the defect site with the bone scoop and will be condensed at the defect such that any air voids are avoided. The previously shaped GTR membrane will be adapted at the site. The flap will be adapted onto the tooth surface so as to achieve primary closure and will be sutured by using 3-0 black silk sutures. In conventional sling suture technique, (A) The needle engages the outer surface of the flap just below the base of the mesial papilla and (B) encircles the tooth without biting into the opposite flap. (C) The outer surface of the same flap of the adjacent interdental area is engaged, ie just below the base of the distal papilla. (D) The suture is returned to the initial site by again encircling around the tooth and not biting into the opposite flap, and the knot is tied. 
Intervention  Gomes Cross Sling Suture for Class II Furcation defects  The periodontal flap surgical procedure in will be performed under local anaesthesia so as to treat class II furcation defects with bone graft and membrane. A crevicular incision will be given on the buccal or lingual aspect at the defect site as per the presence of entry of the defect, extending one tooth adjacent to the involved tooth, both distally and mesially. A full thickness muco-periosteal flap will then be elevated. The granulation tissue will be removed in the furcation defect and a thorough debridement will be carried out with Gracey curettes so as to obtain a smooth hard surface. Any adherent granulation tissue will be trimmed from the flap. A gentle approximation of the flap will be done before the insertion of the Bone graft material, and GTR membrane, so as to determine the coronal extent of GTR membrane needed. After irrigation at the defect with normal saline, bone graft material will be dispensed into the bone well and will be carried to the defect site with the bone scoop and will be condensed at the defect such that any air voids are avoided. The previously shaped GTR membrane will be adapted at the site. The flap will be adapted onto the tooth surface so as to achieve primary closure and will be sutured by using 3-0 black silk sutures. In the cross sling suture technique which is a modification of the above conventional sling suture technique that which is used in comparator group, the first four steps of suturing are identical, except that the knot is not tied at end of step ‘D’. These four steps are as follows: (A) The needle engages the outer surface of the flap just below the base of the mesial papilla and (B) encircles the tooth without biting into the opposite flap. (C) The outer surface of the same flap of the adjacent interdental area is engaged, ie just below the base of the distal papilla. (D) The suture is returned to the initial site by again encircling around the tooth and not biting into the opposite flap but present on the buccal side. (E) The suture needle will then enter into the distal end of the mid-buccal area of the same tooth gingiva and (F) is exited through the mesial end of the same mid-buccal area about 3mm apart horizontally. (G) the suture is then passed through the distal gingival embrasure without engaging the flap. This will create a small cross in the mid-buccal area approximately overlying the trunk area of the furcation of the tooth (H) the suture will be returned to the initial site through the mesial embrasure by encircling the tooth. (I) the knot will now be tied. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. free of any systemic diseases such as diabetes and hypertension and has no contraindication for performing periodontal surgery,
2. having one class II furcation defect in molars, that is determined clinically by instrumentation with a curved Nabers’ probe and confirmed by IOPA Radiographs. 
 
ExclusionCriteria 
Details  1. periodontal surgeries performed in the areas to be treated within last 12 months
2. presence of infections other than periodontal infections at the site to be treated, like endodontic infections.
3. smokers, smokeless tobacco users, known addiction of alcohol, immunocompromised patients, pregnant and/or lactating women.
4. has taken antibiotics in any form in the past 3 months,
5. unable to or not willing to come for routine follow-up for 6 months after periodontal surgery, 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Volumetric measurement of bone defect at test sites using cone beam computed tomography  R0- Before the surgical procedure
R6- 6 months after surgical procedure 
 
Secondary Outcome  
Outcome  TimePoints 
1. Plaque Index (Silness & Löe, 1964)
2. Gingival index (Löe & Silness, 1963)
3. Sulcus Bleeding Index (Mühlemann & Son, 1971)
4. Mobility Index (Miller, 1938)
5. Sulcus Probing depth
6. Relative Vertical Clinical Attachment Level
7. Relative Horizontal Clinical Attachment Level
8. Relative Gingival Margin Level
 		 R0 - Base line [just before starting surgery]
R3 - 3 months after surgery
R6 - 6 months after surgery
 
 
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)   10/12/2024 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aarongomes@hotmail.com].

  6. For how long will this data be available start date provided 25-12-2025 and end date provided 31-12-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Background: Primary closure of the flap after regenerative periodontal surgery for management of class II furcation defects has been commonly done by using interdental direct loop sutures or sling sutures. However, it has been observed that the middle one third of the flap may gape open when using such sling sutures, leading to possible contamination of the regenerative material. Hence a suture called as Gomes’ cross sling suture has been designed to sling the middle third portion of the flap in addition to the interdental sling component, by encompassing another sling around the tooth.

Need of study: There is need to study the effects of using a Gomes’ cross sling suture in periodontal regenerative surgery for class II furcation defects in molars and compare the changes in periodontal parameters when using Gomes’ cross sling suture and conventional suture techniques for such surgeries.

Materials and Methods: Periodontal regenerative surgery will be performed in a cohort of twenty participants presenting with class II furcation defects in molars and indicated for such surgery using bone graft material and GTR membrane. Ten participants will be randomly allotted to control group wherein the furcation defect site will be sutured with conventional sling suture after the regenerative surgery, while in the other ten participants the Gomes’ cross sling suture will be utilized. Periodontal parameters like Plaque index, Gingival index, Sulcus Bleeding index, Mobility index, sulcus probing depth, relative vertical clinical attachment level, relative horizontal clinical attachment level and relative gingival marginal level will be assessed and compared in both groups at time-points of baseline (just before surgery) and 3-months and 6-months after surgery. Cone beam computed tomographic analysis of the furcation defect will be done at baseline and 6-months after surgery. These outcome variables will be compared using standard tests of statistical significance at a level of significance p≤0.05.

 
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