| CTRI Number |
CTRI/2024/11/076319 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two methods to improve gum thickness around dental implants using blood-derived grafts vs gum grafts
|
|
Scientific Title of Study
|
Comparative evaluation of soft tissue parameters and crestal bone changes around implants in sites with thin gingival phenotype using Advanced platelet rich fibrin (A-prf) versus Connective tissue graft (ctg) – A 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 |
Ivaturi Naga Surya Akhila |
| Designation |
Post graduate |
| Affiliation |
GSL Dental College Rajahmundry |
| Address |
Room number -10 ,Department of Periodontics ,GSL Dental College ,Rajahmundry ,Andhra Pradesh
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
7032914895 |
| Fax |
|
| Email |
insakhila2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupama Masapu |
| Designation |
Professor and Head of the department |
| Affiliation |
Gsl Dental College |
| Address |
Room number -10, Department of periodontics, GSL Dental College and Hospital, Rajahmundry ,Andhra Pradesh, India
Pincode-533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9985313267 |
| Fax |
|
| Email |
anu3267@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Ivaturi Naga Surya Akhila |
| Designation |
Post graduate |
| Affiliation |
Gsl Dental College and hospital-Dr NTR University of health sciences ,vijayawada |
| Address |
Room number -10 ,Department of Periodontics ,GSL dental college ,Rajahmundry ,Andhra pradesh
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
7032914895 |
| Fax |
|
| Email |
insakhila2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number -10 ,Department of Periodontics ,GSL dental college ,Rajahmundry ,Andhra pradesh ,533296,India |
|
|
Primary Sponsor
|
| Name |
Ivaturi Naga Surya Akhila |
| Address |
Room number -10 ,Department of Periodontics ,GSL dental college ,Rajahmundry ,Andhra pradesh ,533296 ,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 |
| Dr Ivaturi Naga Surya Akhila |
Gsl dental college and hospital |
Room number -10 ,Department of Periodontics ,Rajahmundry ,Andhra pradesh ,533296
East Godavari
ANDHRA PRADESH |
7032914895
insakhila2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSL DENTAL COLLEGE AND HOSPITAL |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implant placement with Advanced platelet rich fibrin(A-PRF)membrane |
A total of 30 implants will be placed with the implant surgical guide in systemically healthy patients selected based on inclusion criteria,
15 Implants will be randomly allocated to Test (with A-prf membrane)group.
10 mL of blood from the antecubital vein will be drawn and transferred to a test tube without anticoagulant.
The blood sample will be immediately centrifuged at 1500 rpm for 14 minutes.
After centrifugation, the fibrin clot will be pressed between gauze pieces to create a PRF membrane.
After the placement of implant using surgical guide, buccal flap will be elevated and the prepared PRF membrane will be placed and will be secured with sutures. |
| Comparator Agent |
Implant placement with Connective tissue graft(CTG) |
A total of 30 implants will be placed with the implant surgical guide in systemically healthy patients selected based on inclusion criteria, 15 Implants will be randomly allocated to control(with connective tissue graft)group.
Two horizontal and two vertical incisions will be given delineating the graft. The blade will be oriented perpendicular to the palate, and once an adequate soft tissue thickness is obtained, it will be rotated almost parallel to the superficial surface.
Upon harvesting, yellow fatty tissue will be eliminated.
The graft will be de-epithelialized with a 15c blade while keeping the blade parallel to the external surface.
Soft splint will be given to close the palatal wound.
The implants will then be placed and simultaneously augmented with CTG and the flap will be secured with sutures. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Thin gingival phenotype with peri-implant mucosal thickness of 2mm or less and to have 1 missing tooth with the presence of 2 natural adjacent teeth.
Edentulous spaces with adequate ridge dimension for implant placement.
Absence of periapical pathology adjacent to the edentulous site.
Patients who are motivated, highly compliant, with good oral hygiene practice
Patient should not have undergone a bone increasing procedure before or during the dental implant.
Patient should be free from any periodontal disease.
|
|
| ExclusionCriteria |
| Details |
Patients with any systemic disease and medications that will interfere with treatment outcome.
Patients with known risk factors and risk modifiers which can influence the overall outcome of treatment were excluded from the study.
Pregnant and lactating women.
Persons who are not surgically fit for implant placement.
Presence of active periodontal disease. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare and evaluate the width and thickness of keratinized tissue around implants using A-PRF vs CTG.
|
At baseline ,3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare and evaluate the crestal bone levels using intra-oral periapical radiograph around implants placed using A-PRF vs CTG.
|
At 3 months and 6 months |
To compare and evaluate the postoperative pain using visual analogue scale (VAS) in A-PRF group vs CTG group
|
At 1st and 14th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A randomized controlled single blinded study will be conducted. A total number of 30 implants (NORIS, Int. Hex Ti. Tufted implant) will be placed in systemically healthy patients selected based on inclusion criteria. Informed consent will be taken from the patients.15 implants each will be randomly (with the aid of digital software available at: www.randomizer.org) allocated to test (Implant placement along with advanced -platelet rich fibrin) and control (Implant placement along with connective tissue graft) groups. Implants will be placed for both the groups. The peri-implant soft tissue thickness (STT) and keratinized tissue width (KTW) will be measured before implant placement (baseline) and at 3 months and 6 months postoperatively in the test and control groups. The crestal bone level changes are measured at 3months and 6 months. The measurements will be recorded by another operator to prevent the bias.
The sample size was calculated using G*Power 3.1.9.4 software. A sample size of 30 was estimated to be necessary to detect a large effect size (Cohen’s f=0.96) at an alpha of 5% and 80% power using independent samples t test.
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