| CTRI Number |
CTRI/2023/10/059204 [Registered on: 27/10/2023] Trial Registered Prospectively |
| Last Modified On: |
24/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Tooth root as a block graft for augmentation in periodontally hopeless socket |
|
Scientific Title of Study
|
Ridge Augmentation Using Perforated Root Demineralized Dentin Matrix In Periodontally Hopeless Tooth Socket: A Clinico Radiographic Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Namratha Hegde |
| Designation |
Post Graduate |
| Affiliation |
Bapuji Dental College and Hospital Davangere Karnataka |
| Address |
Department Of Periodontics Bapuji Dental College and Hospital Davangere Karnataka.
Department Of Periodontics Bapuji Dental College and Hospital Davangere Karnataka.
Davanagere
KARNATAKA
577004
India |
| Phone |
7829826904 |
| Fax |
|
| Email |
namratha.hegde10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raison Thomas |
| Designation |
Professor |
| Affiliation |
Bapuji Dental College and Hospital Davangere Karnataka |
| Address |
Department Of Periodontics Bapuji Dental College and Hospital Davangere Karnataka.
Department Of Periodontics Bapuji Dental College and Hospital Davangere Karnataka.
Davanagere
KARNATAKA
577004
India |
| Phone |
9886279018 |
| Fax |
|
| Email |
raisonteacher@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namratha Hegde |
| Designation |
Post Graduate |
| Affiliation |
Bapuji Dental College and Hospital Davangere Karnataka |
| Address |
Department Of Periodontics Bapuji Dental College and Hospital Davangere Karnataka.
Department Of Periodontics Bapuji Dental College and Hospital Davangere Karnataka.
Davanagere
KARNATAKA
577004
India |
| Phone |
7829826904 |
| Fax |
|
| Email |
namratha.hegde10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bapuji Dental College and Hospital Davangere Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Namratha Hegde |
| Address |
Department of Periodontics Bapuji Dental College and Hospital Davangere |
| 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 Namratha Hegde |
Bapuji Dental College and Hospital Davangere |
Room no 5 Department of Periodontics Bapuji Dental College and Hospital Davangere
Davanagere
KARNATAKA |
7829826904
namratha.hegde10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with periodontally hopeless tooth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Perforated root demineralized dentin matrix as a block graft
|
Surgical technique: Administration of local anaesthesia (2% lignocaine with epinephrine 1:100,000), at the recipient site and atraumatic extraction of the periodontally hopeless tooth will be done. A CBCT Scan will be taken immediately after extraction to access the ridge defect. Thorough examination of the socket will be done, and it would be cleaned with curettes and irrigated. Preparation of PR-DDM: After extraction of periodontally hopeless tooth, first the soft tissue and the foreign materials will be dissected using curette followed by vigorous cleaning with distilled water. Simultaneously, the tooth will be decoronated and the pulp will be extirpated with the help of reamer file. The apical portion of the root will be sliced approximately 1mm using a diamond disk. A small round bur will be used to fabricate 1mm holes, multiple holes will be added and uniformly distributed to the modified tooth. Demineralization of the perforated root will be carried out using commercially available demineralizing agent, followed by extensive rinse with distilled water will be performed to prepare PR-DDM. Stabilization of PR-DDM: At the recipient site, a crevicular incision will be made around the tooth indicated for extraction. A full thickness flap with vertical releasing incision will be raised. To improve the contact between the root and the cortical bone plate. The PR-DDM will be adapted by minimum levelling of the recipient bed to fit very closely to the recipient site. Subsequently the root shall be predrilled and fixed using suitable size titanium screws to prevent graft mobility. The gap between PR-DDM and the socket will be filled with bone graft. After stabilization of PR-DDM to the recipient site, it will be covered with a collagen membrane.
Tension-free primary closure will be obtained with the help of sutures.
Post-surgical care: Patients will be placed on antibiotic coverage for 7 days and analgesics as required. Chlorhexidine (CHX) mouth rinse (0.12%) 10 ml will be used twice daily for up to 2 weeks. The suture removal shall be done after 10 days. Brushing will be resumed after 14 days. Patients return 1 week after the surgical appointment to evaluate wound healing. Follow-up visits shall be scheduled every month to ensure uneventful healing of the surgical site. CBCT scans will be performed for the grafted sites 4 months after surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
General:
1.Systemically healthy Male and female subjects within the age group of 18-55 years.
2.Subjects with good oral hygiene (plaque index scoring<1.9).
Site specific:
1.Periodontally hopeless maxillary or mandibular single rooted tooth indicated for extraction. 2.Teeth adjacent to the recipient site should be periodontally healthy.
3.The tooth indicated for extraction should be free of recession.
|
|
| ExclusionCriteria |
| Details |
General:
1.Subjects who are smokers.
2.Pregnant women or lactating mothers.
3.Patient not willing to participate in the study or not available for follow up.
Site specific:
1.Subjects with extensive root caries in the tooth indicated for extraction
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare clinical ridge width changes after alveolar ridge augmentation using (PR-DDM) for periodontally hopeless tooth, at baseline and after 4 months post operatively. |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare radiographic ridge width changes, after alveolar ridge augmentation using (PR-DDM) for periodontally hopeless tooth, at baseline and after 4 months post operatively. |
4 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/11/2023 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
BACKGROUND
AND OBJECTIVES:
Tooth
loss results in irreversible alveolar bone resorption, and untreated dental
disease causes alveolar bone lysis that ultimately leads to loss of teeth. Alveolar ridge preservation (ARP) is a method of
decreasing bone resorption following tooth extraction and facilitating
prosthetically driven implant placement. Teeth having more than
50% of alveolar bone loss along with grade III mobility are considered to be periodontally
hopeless. The sockets of such teeth demonstrate a pre-existing periodontal bone
loss. Dentin and bone both consist of 65% inorganic and 35% organic substances.
Autogenous tooth bone graft has physiochemical properties similar to the
autogenous bone autogenous bone grafts. Hence, the aim of
the present study was to evaluate the efficacy of perforated root demineralized
dentine matrix (PR-DDM) in reconstruction of the horizontal and vertical
dimensions of periodontally hopeless tooth sockets. A through literature search was done, and we have not
come across any study that has used PR-DDM for ridge augmentation procedure.
Hence, the aim of the present study is to evaluate the efficacy of PR-DDM in reconstruction of
the horizontal and vertical dimensions of alveolar ridge periodontally hopeless tooth sockets.
METHODOLOGY:
A total of 10 patients within the
age group of 18-55 year will be selected for the study.
The criteria will be maxillary or
mandibular single rooted teeth with
periodontally hopeless prognosis and indicated for extraction. The teeth will be
atraumatically extracted and the deficient sites will be augmented using perforated root demineralized dentine matrix (PR-DDM). Clinical parameters like
alveolar ridge width and soft tissue height and radiographic parameters like
ridge width and apico- coronal defect depth will be assessed at baseline and
after 4 months of augmentation.
|