| CTRI Number |
CTRI/2024/05/067904 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Immediate Implants in extraction sockets with periapical lesions |
|
Scientific Title of Study
|
Immediate Implants in extraction sockets with periapical lesions: A Prospective study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jason Nongmaithem |
| Designation |
PG Student |
| Affiliation |
ITS CDSR Ghaziabad |
| Address |
Room No.8, Department of Oral Maxillo facial Surgery, ITS CDSR GHaziabad
Ghaziabad
UTTAR PRADESH
110093
India |
| Phone |
8730999899 |
| Fax |
|
| Email |
jasonnongmaithem@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushar Dubey |
| Designation |
Reader |
| Affiliation |
ITS CDSR Ghaziabad |
| Address |
Department of Oral Maxillo facial Surgery, ITS CDSR GHaziabad
Ghaziabad
UTTAR PRADESH
110093
India |
| Phone |
8077018989 |
| Fax |
|
| Email |
tushar.dubey123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jason Nongmaithem |
| Designation |
PG Student |
| Affiliation |
ITS CDSR Ghaziabad |
| Address |
Room No.8, Department of Oral Maxillo facial Surgery, ITS CDSR GHaziabad
Ghaziabad
UTTAR PRADESH
110093
India |
| Phone |
8730999899 |
| Fax |
|
| Email |
jasonnongmaithem@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITS Centre for Dental Studies and Research,
Delhi-Meerut Road, Ghaziabad- 201206 Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
ITS Centre for Dental Studies and Research |
| Address |
ITS Centre for Dental Studies and Research
Delhi-Meerut Road, Ghaziabad- 201206 Uttar Pradesh, India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jason Nongmaithem |
ITS Centre for Dental Studies and Research, Ghaziabad |
Room No.8, Department of Oral maxillo facial surgery, ITS CDSR
Ghaziabad
UTTAR PRADESH |
8730999899
jasonnongmaithem@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
imeediate implantation in extraction socket with periapical lesion |
After traumatically extracting the teeth with periapical pathology, the alveolae will undergo meticulous curettage and debridement to eliminate all granulation tissue. Alveolae will be disinfected with 0.12% chlorhexidine-soaked gauzes (applied for one minute) and abundantly irrigated with physiological serum and 0.12% chlorhexidine to eliminate any remaining debris from the alveolus.
Implant placement in both groups will be performed by sequential drilling protocol according to the implant size indicated by the implant manufacturer, by Adin, applying insertion torque 35 N/ cm in all cases. After sequential drilling, the implant placement will be done and cover screw will be placed and suturing will be done. An immediate post op RFA will be done. All patients will have the same post-operative regime, continuing with the prescribed antibiotic treatment for a further 7 days after surgery, 600 mg Ibuprofen (three times a day for 4 days) and applications of 1.2% chlorhexidine gel in the surgical area (three times a day for 10 days).
|
| Comparator Agent |
immediate implantation in extraction sockets without peri-apical lesions |
All patients will undergo pre-operative clinical examination and CBCT evaluation to evaluate the dimensions of the socket, amount of augmentation required and to decide the length and diameter of the implant to be used based on the regional anatomy. In all patients the following pre-operative regimen will be carried out:- 0.12% chlorhexidine mouthwashes (three times a day for 4 days before and 7 days after surgery) and 625 mg amoxicillin/clavulanic acid (three times a day for 4 days before and 7 days after surgery; in case of penicillin allergy, 300 mg clindamycin will be pre- scribed every 8 hours). All surgery will be performed by the same clinician under local anaesthesia. The affected teeth will be extracted with least possible trauma, without damaging the bone cortices checked using a periodontal probe. The surgery will be a flap surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18-65 years of both gender
2.Immediate implants in the aesthetic zones only
3.ASA1 and 2
4.Buccal bone should be upto or greater than midroot level of the tooth.
5.Adequate bone at least 2-3 mm beyond the apex of the tooth or beyond the peri-apical lesion
6.In case of larger peri-apical lesions needing apical buccal access for curettage, adequate 3 dimensional bone should be present cervically.
|
|
| ExclusionCriteria |
| Details |
1.Medically compromised patients.
2.Presence of acute peri-apical pathology
3.Smoking and tobacco users
4.Patient undergoing chemotherapy and radio therapy
5.Pregnant and lactating patients
6.ASA 3 and 4
7.Bone less than 2 mm beyond the apex of the tooth or beyond the peri-apical area
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.RFA to check the implant bone stability at baseline and at 4months of follow up
2.CBCT at baseline and at 4 months of follow up to evaluate the thickness of the labial bone
3. VAS score for presence of pain at week 1 of follow up
|
1.RFA to check the implant bone stability at baseline and at 4months of follow up
2.CBCT at baseline and at 4 months of follow up to evaluate the thickness of the labial bone
3. VAS score for presence of pain at week 1 of follow up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hisptopathological findings of study group
VAS score for presence of pain at week 1 of follow up
|
baseline and
week 1 of follow up
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
24/06/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Immediate
implant placement of dental implants into fresh extraction sockets was shown to
be a predictable and successful procedure when proper protocols were followed. Immediate
implant placement into infected sockets has resulted in variable success rates.
To date results from published studies are inconÂclusive and unclear as to
whether immediate implant placement into sites with periapical infecÂtion
increases the risk of implant failure or successful osseointegration. This study aims to evaluate the efficacy of
immediate implants placement in fresh extracted sockets with peri-apical
lesions as compared to without peri-apical lesions. This Prospective controlled
trial will consist of a Control Group with patients with 12 extraction socket
without peri-apical infection and study Group of patients with 12 extraction
sockets with peri-apical infection. All patients will follow a pre-operative
regimen of 0.12% chlorhexidine mouthwashes and 625 mg amoxicillin/clavulanic
acid. In the study group after traumatically extracting the tooth with
peri-apical pathology, the alveolae will undergo meticulous curettage in all
socket walls to remove all the granulation tissue and will be disinfected. Osteotomy will be prepared on the palatal side by sequential drilling protocol according to
the implant size indicated by the implant manufacturer, by Adin. After
sequential drilling, the implant placement will be done achieving insertion torque
>35 N/ cm in all cases and cover screw will be placed. All cases will be followed
up after 1 week and at 4 months. At week 1 of follow up VAS
score will be used to assess for pain. Implant survival, Implant Stability Quotient
(ISQ) by RFA and Labial bone thickness at the baseline and at 4 months of
follow up will be assessed. |