| CTRI Number |
CTRI/2025/04/084774 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Treatment Of Gum Recession With TCAF Technique And Placental Membrane With Hyaluronic Acid And Laser |
|
Scientific Title of Study
|
Clinical efficacy of tunnelled coronally advanced flap and amnion chorion membrane with the adjunct use of hyaluronic acid and low-level laser therapy for multiple gingival recession: randomized controlled 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 |
Madhumitha M |
| Designation |
postgraduate student |
| Affiliation |
Manipal College of Dental College |
| Address |
Department of Periodontology Room no. 7
4th floor Manipal college of dental sciences
Kasturbha Medical college lighthouse hill road Hampankatta
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8489457979 |
| Fax |
|
| Email |
mmitha.16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashita Uppoor |
| Designation |
Dean |
| Affiliation |
Manipal College of Dental College |
| Address |
Room no 7
Floor 4
Department of Periodontology
Manipal college of dental sciences
Kasturbha Medical college Lighthouse hill road
Hampankatta Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880038082 |
| Fax |
|
| Email |
ashita.uppoor@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ashita Uppoor |
| Designation |
Dean |
| Affiliation |
Manipal College of Dental College |
| Address |
Room no 7
Floor 4
Department of Periodontology
Manipal college of dental sciences
Kasturbha Medical college Lighthouse hill road
Hampankatta Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880038082 |
| Fax |
|
| Email |
ashita.uppoor@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room no 7
Floor 4
Department of Periodontology
Manipal College of Dental Sciences, Mangalore,Karnataka,India -575001 |
|
|
Primary Sponsor
|
| Name |
Madhumitha M |
| Address |
Room no 7
4th floor
Manipal College of Dental sciences
Kasturbha Medical College Lighthouse hill road Hampankatta
Mangalore
Karnataka
India 575001 |
| Type of Sponsor |
Private 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 Madhumitha M |
Manipal college of dental sciences, Mangalore |
Room no.7 , 4th floor, Manipal college of dental sciences, Lighthouse hill road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA |
8489457979
mmitha.16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
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 |
TCAF and ACM |
Tunnelled coronally advanced flap technique with amnion chorion membrane will be performed |
| Intervention |
TCAF with ACM and HA and LLLT |
Tunnelled coronally advanced flap technique with amnion chorion membrane will be performed . 0.2% hyaluronic acid gel will be applied on the root surface and amnion chorion membrane.low level laser therapy will be done on 3rd, 7th , 14th day |
| Intervention |
TCAF with ACM and LLLT |
Tunnelled coronally advanced flap technique with amnion chorion membrane will be performed along with the adjunct use of low level laser therapy on 3rd,7th,14th day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients male or female of age group 18 – 60 years.
2.Teeth selection: Upper arch with multiple recession with clinical evidence of Cairos RT1/RT2 gingival recession.
3.Width of keratinized gingiva atleast 2mm
4.Treated cervical abrasion
5.Patients who agree to participate in the study by signing the informed consent and ability to perform adequate oral hygiene.
5.Full mouth plaque and gingival index score of less than 20%
6.Absence of any malposition tooth
|
|
| ExclusionCriteria |
| Details |
1.Subjects who have received periodontal flap/regenerative therapy within the past 6 months.
2.Patients who have received antibiotic therapy within the past 6 months
3.Pregnant and lactating patients
4.Smokers
5. Fixed orthodontic and removable appliances
6. Patients who demonstrate poor oral hygiene maintenance after Phase I therapy.
7. Systemic illness known to affect the outcomes of periodontal therapy, such as uncontrolled diabetes mellitus, cardiac diseases, immune-compromised (e.g., HIV individuals, under radiotherapy), patients taking medications such as corticosteroids or calcium channel blockers, which are known to interfere with periodontal wound healing.
8.Patients with any known allergy to drugs
9.Patients with severe non carious cervical lesions (NCCL)
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gingival recession depth
Gingival recession width
Percentage of gingival recession defect coverage
Gingival biotype
Width of the keratinized gingiva
Complete root coverage
Mean root coverage
Root coverage Esthetics
Healing Index by Landry et al
|
baseline,3rd day, 7th day, 14th day, 21st day, 3rd month, 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Following will be the secondary outcomes to be measured:
1.Patient Reported Outcome Measures(PROM)
2.Gingival Index
3.Plaque Index
4.Probing Pocket Depth (PPD) |
Baseline,3rd day, 7th day, 14th day, 21st day, 3rd month, 6th month |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Gingival recession (GR) or soft tissue recession
is defined as the displacement of the gingival margin apical to the
cemento-enamel junction (CEJ) of a tooth or the platform of a dental implant. It is associated with poor aesthetics, dentinal hypersensitivity, and
a negative impact on the oral health- related quality of life of an individual. Coronally advanced flap has several disadvantages, hence to overcome these challlenges,, Barootchi and et.al
(2022) introduced a technique, tunnelled coronally advanced flap (TCAF) that
combined the advantage of CAF and tunnelling technique (TUN) to gain access and
improve graft stabilization while preserving the integrity of the papilla, for
treatment. Autograft tissue currently remains the “gold
standard†of periodontal plastic surgery but significantly increases patient morbidity. Amnion chorion membrane (ACM) exert anti-inflammatory,
angiogenic, antifibrotic, antimicrobial effects low immunogenicity. In recent years, low-level lasers have also been
evaluated regarding their efficacy in wound healing‑ process in both medical
and dental fields. Tissue repair phase in wound healing begins on
the third day and lasts about two weeks, involves fibroblast proliferation and
collagen genesis. The supplementation of LLLT at this point leads to expedited
wound-healing events can be used as adjunct in promoting the healing and
improve the outcome of periodontal flap procedures. Hyaluronic acid (HA) is a major component of the
extra cellular matrix in almost all tissues and suppresses tissue break down
activating metalloproteinase inhibitors. HA is a promising adjunct for promoting faster
wound healing when used in post periodontal flap surgery. Combination of photobiomodulation therapy (PBMT)
and HA gel application has proven to show significant clinical results by
improving the healing outcome and decreases the time required for wound healing
and re-epithelialization. Patients with multiple maxillary gingival recession with cairos RT1/RT2 will be treated . Group A : patients will be treated with Tunnelled coronally advanced flap technique followed by placement of amnion chorion membrane. Group B: patients will be treated with Tunnelled coronally advanced flap technique followed by placement of amnion chorion membrane followed by low level laser therapy prior to pack placement Group C: : patients will be treated with Tunnelled coronally advanced flap technique and 0.2% hyaluronic acid gel will be applied in the root surface and amnion chorion membrane. post suturing patients are subjected to low level laser therapy followed by pack placement. Thus, this study aims to evaluate the efficacy of
TCAF and ACM with LLLT and HA. |