| CTRI Number |
CTRI/2025/07/090109 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To observe the effects of two types of bone graft materials covered with
amniotic membrane for the management of periodontal intrabony defects. |
|
Scientific Title of Study
|
A clinical and radiographic evaluation of eggshell hydroxyapatite with amniotic membrane versus bovine bone-derived xenograft with amniotic membrane in human periodontal intrabony defects – A randomized controlled 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 |
Smrithi K |
| Designation |
Post graduate |
| Affiliation |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Bangalore |
| Address |
Room number 2, Department of Periodontology, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
7892101217 |
| Fax |
|
| Email |
smrithikumaravelu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Bhavya Shetty |
| Designation |
Associate Professor |
| Affiliation |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Bangalore |
| Address |
ROOM NUMBER 2, DEPARTMENT OF PERIODONTOLOGY, FACULTY OF DENTAL SCIENCES, RAMAIAH UNIVERSITY OF APPLIED SCIENCES, BANGALORE
Bangalore
KARNATAKA
560054
India |
| Phone |
9880262593 |
| Fax |
|
| Email |
Bhavyashetty123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smrithi K |
| Designation |
Post graduate |
| Affiliation |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Bangalore |
| Address |
Room number 2, Department of Periodontology, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
7892101217 |
| Fax |
|
| Email |
smrithikumaravelu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material support by Dr Vivekanand Kattimani, Sibar Institute of Dental
Sciences, Guntur, Andhra Pradesh -522509 and Dr E K Girija, Periyar University Salem, Tamil Nadu -636011
Under DST Funded Technology Development Project, Govt India |
|
|
Primary Sponsor
|
| Name |
Smrithi K |
| Address |
Room number 2, Department of Periodontology, Faculty of Dental Sciences, M.S. Ramaiah University of Applied Sciences, Bangalore |
| 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 |
| Smrithi K |
Faculty of Dental Sciences, M.S. Ramaiah University of Applied Sciences, Bangalore |
Room number 2, Department of Periodontology
Bangalore
KARNATAKA |
7892101217
smrithikumaravelu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee for Human trials of M S Ramaiah University of Applied Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator agent – Geistlich bovine bone xenograft |
Comparator agent – Geistlich bovine bone xenograft(1 cc) |
| Intervention |
Intervention – eggshell hydroxyapatite for 12 months(time period of the study)
Comparator agent–bovine bone xenograft for 12 months(time period of the study) |
Intervention – eggshell hydroxyapatite (0.5cc) for 12 months(time period of the study)
Comparator agent – Geistlich bovine bone xenograft
(1 cc) for 12 months(time period of the study) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.1.Patients between 25 to 55 years of age (Vani et.al., 2023)
2.Stage III or IV Periodontitis (2017 classification)
3 Probing depth (PD) greater than or equal to 6 mm
4.2 or 3 wall defects
5.Systemically healthy subjects
6.Subjects who have not received any periodontal treatment in the past six months
7.Subjects who have been informed about the study and has given consent.
|
|
| ExclusionCriteria |
| Details |
1. Teeth with pulpal/periapical involvement
2. Teeth with poor prognosis
3. Smokers and alcoholics
4. Pregnant/lactating women
5. Patients with known systemic diseases/conditions
6. Subjects unwilling to participate in the study.
|
|
|
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 |
| The primary outcome measures will be to evaluate the clinical parameters such as Probing pocket depth, Plaque index, Gingival index, Gingival Bleeding Index and Relative attachment level and radiographic changes in bone fill and density in patients with intrabony defects following treatment with eggshell-derived hydroxyapatite with amniotic membrane and bovine bone-derived xenograft with amniotic membrane in periodontal intrabony defects. |
At 3 months and 6 months, patient will be recalled and assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be patient comfort, improved oral hygiene status assessed using Plaque index, Gingival index, Gingival Bleeding Index , reduced mobility, increased clinical attachment level. |
At 3 months & 6 months, patient will be recalled & assessed |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/07/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a randomized
controlled clinical trial to compare the clinical and radiographic efficacy
of eggshell hydroxyapatite with amniotic membrane versus bovine bone-derived
xenograft with amniotic membrane in the treatment of periodontal intrabony
defects. The primary outcome measures will be to evaluate the clinical parameters such as Probing
pocket depth, Plaque index, Gingival index, Gingival Bleeding Index and
Relative attachment level and radiographic changes in bone fill and density in patients with intrabony defects following
treatment with eggshell-derived hydroxyapatite with amniotic membrane and
bovine bone-derived xenograft with amniotic membrane in periodontal intrabony
defects. The secondary outcome will be patient comfort,
improved oral hygiene status assessed
using Plaque index, Gingival index, Gingival Bleeding Index , reduced mobility,
increased clinical attachment level. |