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CTRI Number  CTRI/2026/02/103183 [Registered on: 06/02/2026] Trial Registered Prospectively
Last Modified On: 06/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A Study To Comparatively Evaluate The Clinical And Radiographic Outcomes Of Conventional And Microsurgical Access Flap Technique In Managing Horizontal Bony Defects In Periodontitis Patients  
Scientific Title of Study   Clinical And Radiographic Effectiveness Of Conventional And Microsurgical Access Flap Technique In Managing Horizontal Bony Defects In Periodontitis Patients: A Split Mouth Randomized Clinical Trial  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suchanda Saha 
Designation  Post Graduate Student  
Affiliation  S.C.B Dental College and Hospital, Cuttack , Orissa, India  
Address  Department of Periodontics and Oral Implantology, S.C.B Dental College and Hospital Manglabag Cuttack

Cuttack
ORISSA
753007
India 
Phone  8136071510  
Fax    
Email  suchandasaha7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Subash Chandra Raj 
Designation  Professor and HOD 
Affiliation  S.C.B Dental College and Hospital Cuttack Orissa, India  
Address  Department of Periodontics and Oral Implantology,3rd floor,S.C.B Dental College and Hospital, Cuttack, Orissa, India, 753007

Cuttack
ORISSA
753007
India 
Phone  9437008298  
Fax    
Email  drsubash007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Suchanda Saha 
Designation  Post Graduate Student  
Affiliation  S.C.B Dental College and Hospital, Cuttack, Orissa, India  
Address  Department of Periodontics and Oral Implantology, S.C.B Dental College and Hospital Manglabag Cuttack

Cuttack
ORISSA
753007
India 
Phone  8136071510  
Fax    
Email  suchandasaha7@gmail.com  
 
Source of Monetary or Material Support  
Department of periodontics and oral implantology, S.C.B Dental College and Hospital Cuttack Odisha 
 
Primary Sponsor  
Name  Suchanda Saha  
Address  DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY,3RD FLOOR,S.C.B DENTAL COLLEGE AND HOSPITAL 
Type of Sponsor  Government medical college 
 
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 Suchanda Saha  S.C.B Dental College and Hospital Cuttack  DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY IMPLANTOLOGY,3RD FLOOR,S.C.B DENTAL COLLEGE AND HOSPITAL,CUTTACK, ORISSA, INDIA
Cuttack
ORISSA 
8136071510

suchandasaha7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE(IEC),S.C.B DENTAL COLLEGE AND HSPITAL, CUTTACK,ODISHA  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 
Comparator Agent  CONVENTIONAL GROUP  An intraoral antisepsis will be ensured with a pre-procedural rinse of 0.2% chlorhexidine gluconate and povidone-iodine solution will be used to ensure extraoral antisepsis. 2) After the administration of local anaesthesia, intracrevicular incisions will be placed with BP handle and no 15 surgical blades. 3) Buccal and lingual mucoperiosteal flaps will be elevated using periosteal elevators. 4) Surgical debridement will be carried out to remove subgingival plaque and calculus. 5) Granulation tissue adherent to the root surface and along the crestal surface of the bone defect will be removed with the help of curettes to provide full access and visibility to root surfaces. 6) The surgical site will be irrigated with sterile saline. 7) Simple interrupted sutures will be placed using 4- 0 non resorbable silk suture. 
Intervention  MICROSURGICAL GROUP  An intraoral antisepsis will be ensured with a pre procedural rinse of 0.2% chlorhexidine gluconate, and povidone-iodine solution will be used to ensure extraoral antisepsis. 2) Microsurgery will be carried out under operating microscope using magnification. 3) After local anesthesia, sulcular incisions will be placed with microsurgical ophthalmic blades. Buccal and lingual mucoperiosteal flaps will be elevated using micro- periosteal elevators. With the help of Mini curettes, granulation tissue adherent to the root surface and along the crestal surface of the bone defect will be removed to provide full access and visibility to root surfaces. 5) Granulation tissue adherent to the inner surface of the flap will be removed with the help of mini curettes or microtissue cutting scissors. 6) Simple interrupted sutures will be placed using 6-0 non-resorbable sutures 
 
Inclusion Criteria  
Age From  31.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Interdental CAL detectable at more than or equal to 2 non-adjacent teeth, Buccal or oral CAL more than or equal to 3 mm with pocketing more than 3 mm detectable at more than or equal to 2 teeth, Presence of bleeding on probing, Radiographic evidence of horizontal bone loss in the contralateral quadrants associated, Systemically healthy patient, Patients who are willing to undergo the treatment and agreed to give informed consent, Prior to surgical therapy, patients who will demonstrate acceptable oral hygiene
Vital teeth free from dental caries 
 
ExclusionCriteria 
Details  Patient who have experienced severe periodontitis in the past
Furcation and vertical bone abnormalities necessitating periodontal regeneration
A history of known systemic illnesses such as cancer, immunosuppressive therapy, radiation
therapy, diabetes, hypertension, HIV, bone metabolic abnormalities and blood disorders
Individuals whose blood pattern is aberrant
Patients who take drugs that have been shown to have an impact on periodontal therapy results
Individuals who had received periodontal therapy during the six months prior
Mothers who are nursing or pregnant.
Smokers
Tobacco use in any form.
History of periodontal surgery in the preceding 6 months which can interfere with healing.
The surgical areas exhibiting gingival recession.
Dental mobility at surgery locations. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The outcome variable of the study will be probing pocket depth(PPD),   Baseline, three month and six months 
 
Secondary Outcome  
Outcome  TimePoints 
The outcome variable of the study will be change in plaque index (PI), gingival index (GI), relative attachment level (RAL), relative gingival margin level (RGML),
wound healing index (WHI)16 and patient’s pain perception (VAS)17 from baseline to 3 and 6 months
post-therapy and change in radiographic parameters from baseline to 6 months after the therapy. 
Baseline, three month and six moths 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/02/2026 
Date of Study Completion (India) 25/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
World Workshop, 2017, defined Periodontitis as a chronic multifactorial inflammatory disease, characterized by progressive destruction of the tooth-supporting apparatus, associated with dysbiotic plaque biofilms. A WHO survey conducted in India, along with four other countries, observed a 100% prevalence of periodontal disease (including gingivitis) in adults in India. Periodontitis was found to start after age 15 and at 17 years, 10% of Indian boys had periodontitis. The most prevalent form of bone defect seen in individuals with periodontitis is horizontal bone loss which is also regarded as the least favorable for periodontal regeneration. Patients with horizontal bone abnormalities still have no practical choice except to use an access flap for pocket depth reduction. The purpose of periodontal flap surgery is to increase the visibility and accessibility of the underlying bone and root surfaces which will enable surgeons to carry out regenerative procedures and reduce disease activity. Numerous studies have shown that the improved visual acuity obtained from using an operating microscope improves field illumination with specially made microsurgical instruments enable more precise and non-traumatic manipulation of both soft and hard tissues. It enhances surgical access and prevents the needless removal of tissue, optimize defect debridement and root instrumentation, improve vascularization and increase flap mobility. It also increases the likelihood of achieving better primary wound closure. The use of traditional techniques for access flaps has drawbacks such as gingival recession, exposed root surfaces and opening of gingival embrasures which can result in the formation of black triangles and an unsightly appearance. Operating microscopes are integral to achieving the 
advantages of periodontal microsurgery. These benefits including illumination, magnification and refined surgical skills collectively called the magnification triad are crucial for performing esthetic periodontal plastic surgeries to obtain exemplary and complex details in small scale. All operations performed under magnification beginning at 2.5x and employing an operating microscope or dental loupes are included in periodontal microsurgery. The goal of minimally invasive surgery which was first presented by Harrel and Rees in 1995, is to carefully treat the hard and soft tissues, leave as few scars as possible on the flap and reduce the amount of wound that remains after surgery. The use of smaller more accurate surgical procedures made possible by using magnification instruments like operating microscopes as well as microsurgical instruments and materials is referred as "minimally  
invasive surgery". Operating microscope usage in periodontal regenerative surgery was suggested by Cortellini and Tonetti who noted improved initial wound closure potential from an average of 70% of cases acquired with regular surgery to an exceptional 92% attained with microsurgery. This study is intended to assess and compare the clinical and radiographic efficacy of conventional and microsurgical access flap for the treatment of horizontal bone defects in patients with periodontitis taking into account the findings of the previously stated literature. The null hypothesis is that no significant difference exists between the conventional and microsurgical access flap technique in 
managing horizontal bony defect in periodontitis patients.
 
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