| CTRI Number |
CTRI/2018/02/011699 [Registered on: 05/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To check increase in height of bone after sinus lift procedure |
|
Scientific Title of Study
|
Radiographic evaluation of maxillary sinus floor height after direct maxillary sinus augmentation using β-tricalcium phosphate and platelet rich fibrin. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nihal Devkar |
| Designation |
Professor |
| Affiliation |
Sinhgad Dental College and Hospital Pune |
| Address |
Sinhgad Dental College and Hospital,
Vadgaon Budruk, Off Sinhgad Road, Pune-411041
maharashtra
Pune MAHARASHTRA 411041 India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Diganta Thube |
| Designation |
PG Studentt |
| Affiliation |
Sinhgad Dental College and Hospital Pune |
| Address |
Sinhgad Dental College and Hospital
Vadgaon Budruk Off Sinhgad Road Pune-411041
maharashtra
Pune MAHARASHTRA 411041 India |
| Phone |
9028273960 |
| Fax |
|
| Email |
digantathube@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nihal Devkar |
| Designation |
Professor |
| Affiliation |
Sinhgad Dental College and Hospital Pune |
| Address |
Sinhgad Dental College and Hospital
Vadgaon Budruk Off Sinhgad Road Pune-411041
maharashtra
Pune MAHARASHTRA 411041 India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sinhgad Dental College and Hospital
Vadgaon Budruk Off Sinhgad Road Pune-411041
maharashtra |
|
|
Primary Sponsor
|
| Name |
Sinhgad Dental College and Hospital |
| Address |
Sinhgad Dental College and Hospial
Vadgaon Budruk Off Sinhgad Road Pune-411041
maharashtra |
| Type of Sponsor |
Private medical college |
|
|
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 Nihal Devkar |
Sinhgad Dental College and Hospital |
Dept of Periodontology, Room no.4, Vadgaon Bk, Off sinhgad road, Pune Pune MAHARASHTRA |
9420481441
drdevkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sinhgad Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
12 sites presenting with moderately or severely atrophic posterior maxilla with vertical residual ridge height ≤ 5mm., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
beta tricalcium phosphate alloplast |
Mucoperiosteal flap will be elevated and a bony window will be created on the lateral wall of the maxillary sinus using a round diamond bur under sufficient cooling.The Schneiderian membrane will be carefully elevated using sinus elevators and the bony wall gently pushed inside the sinus cavity. β-TCP will be used for the sinus elevation. Evaluation of the outcome after 5 months period. |
| Comparator Agent |
platelet rich fibrin |
platelet rich fibrin autologous, obtained from a dose of 20 ml intravenous blood, Route- direct delivery to the extraction site. assessment duration- 5 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients between the age group 18 – 65 years.
2.Maxillary partial (unilateral or bilateral) edentulism involving the premolar/molar areas.
3.Patients willing for placement of implant in maxillary edentulous posterior region.
4.Patients presenting with moderately or severely atrophic posterior maxilla with vertical residual ridge height ≤ 5mm.
5.Patients willing to participate and sign an informed consent.
6.Patients who are compliant.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are systemically compromised.
2.Smoking > 5 cigarettes per day during the 3 months preceding the study.
3.Maxillary sinus pathology.
4.Pregnant and lactating females.
5.No untreated periodontal or periapical pathology especially with teeth adjacent to sinus floor.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a.Vertical distance from alveolar ridge crest to the inferior most point on the sinus floor pre-operatively
b.Distance from alveolar ridge crest to the raised sinus floor post-operatively after 5 months.
|
a.Vertical distance from alveolar ridge crest to the inferior most point on the sinus floor pre-operatively
b.Distance from alveolar ridge crest to the raised sinus floor post-operatively after 5 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="12" Sample Size from India="12"
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)
|
12/05/2016 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The rehabilitation of patients affected by posterior maxillary atrophy by the aid of implant-supported fixed prosthesis presents a challenge in many cases. Frequently, the available residual alveolar ridge is insufficient for the placement of dental implants because of alveolar bone resorption, pneumatization of the maxillary sinus, or their combination. Maxillary sinus floor augmentation is the treatment of choice when insufficient alveolar bone height prevents placement of dental implants in the posterior edentulous maxilla. Maxillary sinus augmentation was first presented by Tatum in 1976. Long term results showed that this technique can be an effective treatment option. Grafting materials used in sinus floor augmentation procedure can be in the form of bone blocks (cancellous or corticocancellous) or bone particles. Although autogenous bone is considered the gold standard because of its high biocompatibility and osteoinductive potential, its disadvantages include extra surgical site, donor site morbidity, increased cost and total operation time. To reduce the problems associated with autografts, many authors have advocated the use of bone substitutes such as demineralized freeze-dried bone allograft(DFDBA), mineralized freeze-dried bone allograft(FDBA), xenografts, hydroxyapatite preparations, calcium sulfate preparations, as well as growth factors embedded in different carrier materials to augment the floor of the maxillary sinus. Amongst alloplasts, β-tricalcium phosphate (β-TCP) is a biocompatible alloplast and is of the highest purity. β- TCP has a crystalline structure and its porosity provides optimal biologic properties, i.e., osteoconductivity and total resorbability. It has calcium to phosphate ratio of 1:1.5, with particle size ranging from 0.5 to 1.0 mm and resorbs progressively, releasing calcium and phosphate ions, which promote new bone formation within 3-6 months. It has found its multiple clinical applications in dentistry in the treatment of bone defects, ridge and socket preservations, and periodontal osseous defects including furcation defects. Platelet rich fibrin (PRF) is an autologous preparation of concentrated platelets created by centrifugation of a patient’s blood. The use of PRF during surgical procedure is a current treatment concept used to accelerate wound healing and tissue maturation. It can be used directly as a clot or after compression as a strong membrane. Aim:
To radiographically evaluate the newly formed bone after direct maxillary sinus floor augmentation using β-TCP and platelet rich fibrin (PRF). Objectives:
1. To evaluate distance from alveolar ridge crest to the inferior most point on the sinus floor pre-operatively. 2. To evaluate distance from alveolar ridge crest to the raised sinus floor post-operatively after 5 months. 3. To evaluate increase in height of alveolar ridge crest post-operatively after 5 months. Sample size: 12 |