| CTRI Number |
CTRI/2020/12/029817 [Registered on: 15/12/2020] Trial Registered Prospectively |
| Last Modified On: |
14/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pin hole Surgical technique and Semilunar Coronally Repositioned flap for treatment of Gingival Recession |
|
Scientific Title of Study
|
comparative evaluation of pin hole surgical technique and semilunar coronally repositioned flap for treatment of gingival recession |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kunche lavanya |
| Designation |
MDS |
| Affiliation |
Institute of Dental Sciences |
| Address |
Department of Periodontology and Implantology,
Institute of Dental Sciences,Pilibith bypass road, Bareilly,
Uttarpradesh-243006
India
Bareilly UTTAR PRADESH 243006 India |
| Phone |
8466904776 |
| Fax |
|
| Email |
drklavanyaperio@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manvi Agarwal |
| Designation |
professor |
| Affiliation |
Institute of Dental Sciences |
| Address |
Department of Periodontology and Implantology,
Institute of Dental Sciences,Pilibith bypass road, Bareilly,
Uttarpradesh-243006
India Department of Periodontology and Implantology,
Institute of Dental Sciences,Pilibith bypass road, Bareilly,
Uttarpradesh 243006 Bareilly UTTAR PRADESH 243006 India |
| Phone |
9457540800 |
| Fax |
|
| Email |
agarwalmanvi25@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
kunche lavanya |
| Designation |
MDS |
| Affiliation |
Institute of Dental Sciences |
| Address |
Department of Periodontology and Implantology,
Institute of Dental Sciences,Pilibith bypass road, Bareilly,
Uttarpradesh-243006
India
Bareilly UTTAR PRADESH 243006 India |
| Phone |
8466904776 |
| Fax |
|
| Email |
drklavanyaperio@gmail.com |
|
|
Source of Monetary or Material Support
|
| rohilkhand medical college and hospital Institute of dental sciences near pilibhit bypass 243006 |
|
|
Primary Sponsor
|
| Name |
Dr Lavanya Kunche |
| Address |
institute of dental sciences rohilkhand medical college and hospital pilibhit bypass bareilly uttar pradesh 243006 |
| Type of Sponsor |
Other [private dental 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 |
| lavanya kunche |
institute of dental sciences |
rohilkhand medical college and hospital institute of dental sciences department of periodontology and implantology pilibhit bypass Bareilly UTTAR PRADESH |
8466904776
drklavanyaperio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute of dental sciences bareilly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M272||Inflammatory conditions of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
pinhole surgical techique |
involves a round incision of 2mm above the gingival margin. Used s a root coverage technique. |
| Intervention |
semilunar coronally repositioned flap technique |
a semilunar incison is given 2mm away from gingival margin not extending deep into the interdental gingiva. Used s a root coverage technique with better results. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Presence of maxillary single or multiple buccal recessions in the anterior region classified as class I
2. Absence of restoration or crowns and non-identifiable cemento-enamel junction(CEJ)
3. Plaque and bleeding score should be <25% |
|
| ExclusionCriteria |
| Details |
1. Systemically compromised individuals with diabetes mellitus, history of malignancies, bleeding disorders or any other chronic inflammatory disease eg-rheumatoid arthritis.
2. Pregnant women and lactating mothers.
3. Patients on antibiotic therapy.
4. Patients who underwent any surgical periodontal therapy in the last six months.
5.Smokers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the clinical outcome of Pin hole surgical technique and Semilunar coronally advanced flap in maxillary anterior region of Miller’s class I gingival recession. |
baseline, 3 months and 6 months post-operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the recession coverage in pin hole surgical technique.
To assess the recession coverage in semilunar coronally repositioned flap technique.
To compare the effectiveness of recession coverage by both the surgical techniques and find out if any technique is superior to other.
|
baseline, 3 months and 6 months post-operatively. |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
23/12/2020 |
| 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="3" Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Intervention
/ Procedure:
Procedure performed by a single
operator. The patients’ will be explained about the surgical procedures (Appendix
I) and the possible outcomes in their vernacular language as well as written
informed consent (Appendix II) shall be obtained. The demographic data of all
the subjects will be recorded on the customized case history proforma (Appendix
III).
The study will be conducted in
patients with single or multiple Miller’s class I gingival recession defects.
Clinical parameters like recession height (RH), the distance from the CEJ to
gingival margin, recession width (RW), meiso-distal diameter at the CEJ,
probing sulcus depth (PD), clinical attachment level (CAL), the sum of
recession depth and probing depth, and width of keratinized tissue (KTW) i.e.,
distance from marginal gingiva to the mucogingival junction will be assessed.
In case of semilunar coronally repositioned flap, a
semilunar incision, will be given following the curvature of the free gingival
margin. The incision will curve apically far enough mid facially to ensure that
the apical part of the flap rests on bone after it is brought down to cover the
exposed root.
Incision will end into the papillae on each end of
the tooth, but not all the way to the tip of the papillae, at least 2 mm will
be left on either side of the flap. Using a 15c blade, split thickness
dissection will be made from the initial incision line coronally, connected
with an intrasulcular incision made mid facially.
Mid facial tissue will be then coronally positioned
to the CEJ or to the height of adjacent papillae in case of interproximal
recession. Tissue will be held in place against the tooth with moist gauze for
5 min.
In case of pin hole surgical technique, a minimal
horizontal incision of 2 to 3mm will be made in the alveolar mucosa near the
base of the vestibule apical to recipient site. Specially designed instruments
[Transmucosal periosteal elevators right and left] are inserted through the
entry of incision to elevate full thickness flap and will be guided by
visualization of the shape and movement of the instruments through the mucosa
and gingival tissue. This interproximal extension of the flap will result in a
freely movable flap, which will be then positioned coronally to extend beyond
the CEJ. For stabilization of flap, sutures will be used. |