| CTRI Number |
CTRI/2024/03/064826 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of gum loss using blood derived membrane and tissue obtained from palate |
|
Scientific Title of Study
|
Evaluation of the clinical efficacy of platelet rich fibrin obtained through the horizontal spin technique along with coronally advanced flap and connective tissue graft obtained by de-epithelized free gingival graft in the treatment of gingival recession - A Prospective comparative 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 |
Kavitha sridhar |
| Designation |
Post graduate student |
| Affiliation |
SRM dental college |
| Address |
SRM dental college
Department of periodontics PG Block
Bharathi salai
Chennai
Tamil nadu
SRM dental college
Department of periodontics, PG block
Bharathi salai
Chennai
Tamil nadu
Chennai
TAMIL NADU
600089
India |
| Phone |
7708468555 |
| Fax |
|
| Email |
kavithasreedhar97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama Tadepalli |
| Designation |
Professor |
| Affiliation |
SRM dental collge |
| Address |
SRM dental college
Department of periodontics PG Block
Bharathi salai
Chennai
Tamil nadu
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupama Tadepalli |
| Designation |
Professor |
| Affiliation |
SRM dental collge |
| Address |
SRM dental college
Department of periodontics PG Block
Bharathi salai
Chennai
Tamil nadu
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM dental college and hospital,
Bharathi salai, Ramapuram
Chennai 600089 |
|
|
Primary Sponsor
|
| Name |
Kavitha |
| Address |
SRM Dental college
Department of periodontics PG block
Bharathi salai
Chennai Tamil nadu |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 |
| kavitha |
SRM dental college |
SRM dental college
Department of periodontics PG block
Bharathi salai Ramapuram
Chennai
Tamil nadu
Chennai
TAMIL NADU |
7708468555
kavithasreedhar97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board, SRM Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Gingival recession sites treated with coronally advanced flap and de-epitheliazed free gingival graft
After treatment patients will be followed for a period of 6 months. Treatment outcomes will be assessed at 3 and 6 months. |
| Intervention |
Test group |
Gingival recession sites treated with coronally advanced flap and platelet rich fibrin obtained by horizontal spin protocol. After treatment patients will be followed for a period of 6 months. Treatment outcomes will be assessed at 3 and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Gingival recession defects in maxillary anteriors and premolars (Cairo’s RT1 & RT2 class of recession)
2. Sites with minimum depth of recession ≥2mm.
3. Isolated or multiple adjoining recession involving ≤3 teeth.
|
|
| ExclusionCriteria |
| Details |
1. Sites with probing pocket depth ≥4mm.
2. Teeth with mobility and/or associated with trauma from occlusion.
3. Sites with dental caries and prosthetic restorations.
4. Patients who exhibit unacceptable oral hygiene compliance during/or after phase Ι therapy.
5. Smokers.
6. Pregnant and lactating women.
7. Patients with known platelet disorders or using any medication that are known to interfere with platelet function.
8. Patients with systemic conditions or disease influencing the course of periodontal disease and therapy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare the changes in the recession height (RH)
2.To assess and compare the percentage of Complete root coverage (CRC%)
|
Baseline and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the changes in the following parameters between the study groups before and after therapy
1. Width of keratinised gingiva (WKT)
2. Gingival phenotype
|
baseline and six months |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 is defined as the apical displacement of gingival margin to the cemento enamel junction (CEJ) exposing the root surface (Gustavo et al 2021 ). The causative factors include faulty tooth brushing, underlying periodontal disease, malaligned tooth, high frenal attachment causing marginal gingival pull, subsequently leading to the exposure of root causing esthetic concerns hypersensitivity, plaque retention and caries to the patients. Among the various surgical treatment strategies, the coronally advanced flap technique (CAF) combined with connective tissue graft (CTG) is considered as the gold standard protocol in the management of gingival recession resulting in complete root coverage along with improving keratinized tissue height and gingival thickness. A recent modification by zuchelliet al (2010), known as De-epithealized gingival graft (DGG) enables the clinician to obtain collagen rich fibrous connective tissue from lamina propria of the palate, with minimal amount of fatty and glandular tissue, than the previously mentioned sub epithelial connective tissue graft harvesting techniques. However, drawbacks of harvesting autogenous grafts include palatal morbidity as a result of the secondary surgical site and the patient’s fear of pain. Studies have reported that horizontal centrifugation of PRF was superior at accumulating platelets and leukocytes when compared to the results from standard fixed angle centrifuges (Richard J.Miron et al 2020). In this clinical study we propose to compare out comes of the PRF obtained by the horizontal centrifugation method and coronally advanced flap with connective tissue graft (CTG) obtained by de-epithelized FGG for a follow up period up to 6 months
|