| CTRI Number |
CTRI/2025/08/093894 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two materials for gum and bone healing in patients with dental implants. |
|
Scientific Title of Study
|
Comparative Evaluation Of Soft and Hard Tissue Parameters in Immediate Implant Placement using Porcine-Derived Collagen Matrix with Demineralized Freeze-Dried Bone Allograft Vs Enamel Matrix Derivative with Demineralized Freeze-Dried Bone Allograft: A 6-Months Clinico Radiological Study |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Preeti Upadhyay |
| Designation |
Professor and Head of Department |
| Affiliation |
Inderprastha Dental College and Hospital |
| Address |
Department of Periodontology, Inderprastha Dental College and Hospital
Sahibabad, Ghaziabad, Uttar Pradesh – 201010
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9910012441 |
| Fax |
|
| Email |
preeti.mynk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pulkit Kaur Basra |
| Designation |
Postgraduate Student, Department of Periodontology |
| Affiliation |
Inderprastha Dental College and Hospital |
| Address |
Department of Periodontology, Inderprastha Dental College and Hospital
Sahibabad, Ghaziabad, Uttar Pradesh – 201010
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
8920847805 |
| Fax |
|
| Email |
basra.ppulkit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pulkit Kaur Basra |
| Designation |
Postgraduate Student, Department of Periodontology |
| Affiliation |
Inderprastha Dental College and Hospital |
| Address |
Department of Periodontology, Inderprastha Dental College and Hospital
Sahibabad, Ghaziabad, Uttar Pradesh – 201010
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
8920847805 |
| Fax |
|
| Email |
basra.ppulkit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Society of Periodontology (ISP) [Grant under review], #721, Phase 3B-1, Mohali – 160059, Punjab, India |
|
|
Primary Sponsor
|
| Name |
Grant application under review (Indian society of periodontology) |
| Address |
Grant application from ISP under process. Final confirmation awaited. |
| Type of Sponsor |
Other [Pending professional society grant ] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pulkit Kaur Basra |
Inderprastha Dental College and Hospital |
Department of Periodontology, Sahibabad, Ghaziabad, Uttar Pradesh – 201010
Ghaziabad
UTTAR PRADESH |
8920847805
basra.ppulkit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Inderprastha Dental College & Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Enamel matrix derivative with DFDBA |
Immediate implant placement in extraction sockets using enamel matrix derivative mixed with demineralized freeze-dried bone allograft (DFDBA). |
| Intervention |
Porcine-derived collagen matrix with DFDBA |
Immediate implant placement in extraction sockets using porcine-derived collagen matrix mixed with demineralized freeze-dried bone allograft (DFDBA). |
|
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Inclusion Criteria
|
| Age From |
22.00 Day(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects aged between 22 to 70 years, including both male and female participants.
Patients having at least one tooth scheduled for extraction due to advanced periodontal destruction, extensive carious lesions, root fracture, or failing endodontic treatment.
Patients with no relevant medical history.
Patients maintaining good oral hygiene with a plaque index score less than or equal to 1 as per Silness and Loe, 1964.
Radiographic evidence of adequate buccal and lingual bone measuring at least 1 millimeter.
Patients who are willing and able to comply with the treatment protocol. |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women.
Radiographic evidence of inadequate buccal bone measuring less than 1 millimeter.
Medically compromised patients or those taking immunosuppressive drugs that may complicate the treatment outcome.
Patients with systemic diseases that can influence the outcome of treatment.
Patients undergoing anticoagulant therapy.
Patients with special needs or those who are physically challenged.
Patients who use smokeless tobacco or are active smokers.
Patients who fail to provide signed informed consent.
Patients with a history of allergy to any of the materials used in the study.
Patients who are unable or unwilling to maintain proper oral hygiene. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in gingival thickness, keratinized mucosa width, and crestal bone level between Group A (Porcine-derived collagen matrix with DFDBA) and Group B (Enamel matrix derivative with DFDBA) during immediate implant placement. |
Baseline, 4 weeks, 16 weeks and 6 months
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Patient-reported healing and acceptance, ease of handling of biomaterials by operator, and evaluation of long term soft tissue stability. |
Baseline, 1 week, 4 weeks, 16 weeks and 6 months. |
|
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Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
26/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study aims to compare the effectiveness of two different biomaterials: Porcine-Derived Collagen Matrix with Demineralized Freeze-Dried Bone Allograft, and Enamel Matrix Derivative with Demineralized Freeze-Dried Bone Allograft when used in immediate implant placement. A total of 22 patients will be recruited and randomly assigned to two groups. Group A will receive Porcine-Derived Collagen Matrix with DFDBA. Group B will receive Enamel Matrix Derivative with DFDBA. Clinical and radiographic evaluations will be performed to assess changes in gingival thickness, keratinized mucosa width, and crestal bone level at baseline, 4 weeks, 16 weeks, and 6 months. The total study duration is 6 months.
This study is being conducted by Dr Pulkit Kaur Basra, Postgraduate Student, Department of Periodontology, Inderprastha Dental College and Hospital, under the guidance of Dr Preeti Upadhyay, Professor and Head of Department, as part of an MDS dissertation research project.
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