| 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
|
|
|
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
|
|
|
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. |