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CTRI Number  CTRI/2025/05/087904 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 11/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of gum recession treatment with or without using microscope 
Scientific Title of Study   Comparative evaluation of recession coverage with modified coronally advanced flap and deepithelialized gingival graft using microsurgical and conventional approach: 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  A Ajaisha 
Designation  Post graduate student 
Affiliation  SCB dental college and hospital 
Address  Department of periodontics and oral implantology SCB dental college and hospital

Cuttack
ORISSA
753007
India 
Phone  7708708353  
Fax    
Email  dr.ajaishaarul@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSubash Chandra Raj 
Designation  Professor and Head 
Affiliation  SCB dental college and hospital 
Address  Department of periodontics and oral implantology SCB dental college and hospital

Cuttack
ORISSA
753007
India 
Phone  9437008298  
Fax    
Email  drsubash007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  A Ajaisha 
Designation  Post graduate student 
Affiliation  SCB dental college and hospital 
Address  Department of periodontics and oral implantology SCB dental college and hospital

Cuttack
ORISSA
753007
India 
Phone  7708708353  
Fax    
Email  dr.ajaishaarul@gmail.com  
 
Source of Monetary or Material Support  
SCB dental college and hospital 
 
Primary Sponsor  
Name  A Ajaisha 
Address  Department of periodontics and oral implantology SCB dental college and hospital Mangalabag Cuttack 753007 Odisha India 
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 
AJAISHA A  SCB dental college and hospital  3rd floor,DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY
Cuttack
ORISSA 
7708708353

dr.ajaishaarul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee - SCB dental college and hospital  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  Recession coverage with modified coronally advanced flap and de-epithelialized gingival graft using conventional approach  The total duration of this procedure approximately 2 hours. Povidone iodine solution will be used for extraoral and intraoral sepsis.The site will be anaesthetized using local anesthesia. Lignocaine hydrochloride with Adrenaline at 1:80,000 will be used. Zucchellis technique will be used to raise the flap. The horizontal incision will be made up with oblique submarginal incisions in the interdental areas. It will continue with the intrasulcular incisions at the recession defects. The envelope flap will be raised with a split-full-split approach in the coronal apical direction. Then epithelium will be removed from the facial portion of anatomic interdental papillae. Flap mobilization will be done with a sharp dissection into the vestibular lining mucosa. It will be followed by coronal mobilization of the flap and suturing (sling sutures) of the flap. A horizontal double mattress suture will be performed to reduce lip tension on the marginal portion of the flap.The harvesting of the palatal graft and the buccal recession coverage will be done under naked eye without any magnification.A second surgical site will be created on the palate. The graft will be taken from the maxillary palatal area, ranging from the canine to first molar. Two horizontal and two vertical incisions will be traced to delimitate the area to be grafted. The coronal incision will be performed 1- 1.5mm apical to the soft tissue margin of the adjacent teeth. The blade will be kept almost perpendicular to the bone plate along the coronal incision, and once sufficient soft tissue has been acquired, it will be rotated so that it is approximately parallel to the superficial surface. While moving the blade apically, the grafts thickness will be kept constant at about 1.5mm. The graft will be de- epithelialized with a 15c blade. Palatal donor area will be protected by an acrylic stent. Graft will be sutured to the recipient site and the flap is coronally advanced and sutured  
Intervention  Recession coverage with modified coronally advanced flap and de-epithelialised gingival graft using microsurgical approach   The total duration of the intervention is approximately 2 hours. Povidone iodine solution will be used for extraoral and intraoral sepsis.The site will be anaesthetized using local anesthesia. Lignocaine hydrochloride with Adrenaline at 1:80,000 will be used. Zucchellis technique will be used to raise the flap. The horizontal incision will be made up with oblique submarginal incisions in the interdental areas. It will continue with the intrasulcular incisions at the recession defects. The envelope flap will be raised with a split-full-split approach in the coronal apical direction. Then epithelium will be removed from the facial portion of anatomic interdental papillae. Flap mobilization will be done with a sharp dissection into the vestibular lining mucosa. It will be followed by coronal mobilization of the flap and suturing (sling sutures) of the flap. A horizontal double mattress suture will be performed to reduce lip tension on the marginal portion of the flap.The entire procedure is done under operating microscope. A second surgical site will be created on the palate. The graft will be taken from the maxillary palatal area, ranging from the canine to first molar. Two horizontal and two vertical incisions will be traced to delimitate the area to be grafted. The coronal incision will be performed 1- 1.5mm apical to the soft tissue margin of the adjacent teeth. The blade will be kept almost perpendicular to the bone plate along the coronal incision, and once sufficient soft tissue has been acquired, it will be rotated so that it is approximately parallel to the superficial surface. While moving the blade apically, the grafts thickness will be kept constant at about 1.5mm. Palatal donor site will be protected with the use of acrylic stent.The graft will be de- epithelialized with a 15c blade.The graft will be sutured to the recipient bed and the flap is coronally advanced and sutured using 6-0 nonabsorbable sutures. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age >18 years
Single or multiple teeth with RT1 Gingival Recession present bilaterally
Systemically healthy patient
Good level of oral hygiene with Full Mouth Bleeding Scores (FMBS) <20% and Full Mouth Plaque Index Score (FMPS) <20%
Vital teeth free from dental caries
No history of periodontal surgery in the preceding 6 months which can interfere with healing.
Non-smokers 
 
ExclusionCriteria 
Details  With known systemic illness such as diabetes mellitus, arthritis and osteoporosis
Patients on systemic medications such as corticosteroids or calcium channel blockers taking long term NSAIDS or taking bisphosphonates or calcium supplements.
Use of tobacco in any form and alcohol
Teeth with Grade II and Grade III mobility
Immunocompromised individuals
Pregnant or lactating females
Tooth with hopeless prognosis
Non-vital tooth with or without periapical pathology
History of radiotherapy in the preceding 1 year in head and neck region 
 
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 
Mean root coverage   3 months
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Probing depths, Clinical attachment levels, Full mouth bleeding index, Plaque index  3 months
6 months 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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   Phase 2 
Date of First Enrollment (India)   10/06/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  

The displacement of the gingival margin apical to the cementoenamel junction is known as gingival recession or marginal soft tissue recession. Though tooth loss rarely occurs as a result of it, consequences such as root sensitivity, tooth decay, abrasion, and aesthetics have always been of great concern.Improper tooth brushing, periodontal disease, malaligned teeth, alveolar bone dehiscence, thin gingival biotype of gingiva covering a nonvascularized surface of the root, abnormal attachment of muscle, and occlusal trauma are some of the etiological factors that are linked to its occurrence.

For root coverage, many different types of surgical procedures have been proposed, such as lateral displaced flaps, coronally positioned flaps (CPF), connective tissue grafts, and other combination techniques. The use of coronally advanced flaps (CAF) for adequate root coverage is strongly supported by the literature. De Sanctis and Zucchelli modified the coronally advanced flap technique by elevating split- full- split thickness flap with oblique releasing incisions. This technique was successful in attaining complete root coverage, and the clinical outcomes sustained over a three-year period.

Due to its high predictability and capacity to enhance the width and thickness of keratinized tissue, connective tissue graft is regarded as the gold standard. Due to limited donor tissues, bigger dimension of CTG is needed. This is one of the limitations of CTG. To overcome the limitations of CTG, de-epithelialized gingival graft (DGG), was invented by Zucchelli and coworkers. It is harvested as a free gingival graft and then extra- orally de-epithelialized. Using this method, palatal harvesting is possible irrespective of fibromucosa thickness. In comparison to SCTG, connective tissue generated via the DGG method is thought to be more stable and to consist of less fatty and glandular tissue. Research has demonstrated the efficiency of CAF + DGG in achieving root coverage.


The aim of periodontal plastic surgery is to develop less invasive techniques that favor rapid healing, less postoperative discomfort, and higher patient satisfaction, in addition to providing satisfactory results of root covering based on clinical observations. Because the surgical microscope provides adequate illumination and magnification of the operating field, it has been employed to achieve these goals. These developments may enable more accurate and less traumatic tissue manipulation, allowing for healing by first intention and exact coadaptation of wound margins.

Studies have conclusively shown that when compared to conventional or macrosurgical approaches, periodontal plastic surgical treatments planned for root coverage and done under a surgical microscope improved the treatment outcomes at a clinically significant level.

Considering all the above factors, the aim of this present split mouth randomized clinical trial is to compare the root coverage percentage and other clinical outcomes in patients treated with coronally advanced flap and de-epithelialized gingival graft using conventional and microsurgical approach. 

 
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