| 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
|
|
|
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
|
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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. |
|
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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. |