Capability of sealing gel on bacterial microleakage at implant abutment junction - a randomized clinical control trial

Phase 3

Completed

Conditions: Disorder of gingiva and edentulousalveolar ridge, unspecified,

Registration Number: CTRI/2023/08/056992

Lead Sponsor: Pravara institute of medical sciences

Brief Summary: This study is randomized clinical Control trial consisting of 2 groups with an aim , the effect of sealing gel on bacterial microleakage at implant abutment junction

**Objective**

1)Type of Colony seen in samples with and without  sealing gel

2) No. of Colony seen in samples with and without  sealing gel

**Randomization technique**

Each eligible patient who have opted to undergo implant treatment will be subjected to random lottery method.

Each patient will be asked to pick up a lottery chit out of the 4 chits. The chits include:

1)RS (Right side with sealing gel )

2)LS (Left side with sealing gel)

3)RWS (Right side without sealing gel)

4)LWS(Left side without sealing gel)

All patient satisfying the Inclusion criteria and Exclusion criteria of this randomized clinical control trial will be include in this study A total sample size of 30 will be selected-Study groups

Sample size: 15 for each group (30 Total samples) with 2 site of implants in each ,test and control site will be allocated randomly using the above mentioned lottery system

**VARIABLES**

1)Type of colony â€“ sealing gel

2)Type of colony â€“without sealing gel

3) No. of colony seen - sealing gel

4) No. of colony seen - without sealing gel

**1.**     **Patient selection:**

Patient requiring implant supported prosthesis.

**2.**     **Second stage surgery and Sterile field assessment**

Implant will be isolated with sterile cotton wool rolls and suction. At the time of Second stage surgery before injecting gap seal in internal compartment of implant and placing abutment, sterilization of compartment with chlorhexidine solution (30sec-2min) both group, prior injecting sealing gel in group A and group B(without sealing gel), to assess sterile field, introduce 10 Âµl of sterile saline into the internal compartment of the implant with Insulin syringe (as determined prior to the commencement of the study, the internal volume of the implants was able to accommodate saline volume in excess of 10 Âµl) and immediately drawn back up from internal compartment of the implant and microbial assessment will be done by culturing saline sample**.** A sterile syringe will be used and discarded after each sample.

**3.**     **Microleakage****assessment**

After removal of abutment (15-20 days)immediatelyInsulin syringe will be used to introduce of sterile saline into the internal compartment of the implant, the internal volume of the implants will able to accommodate saline volume. A sterile syringe will be used and discarded after each sample. The saline will immediately drawn back up and transferred into a sterile Brain Heart Infusion Broth (BHI) and microbial assessment will be done by CFUs and measured in both sealing gel and conventional method. Any calculus present on the implant neck will be removed

  **STATISTICAL ANALYSIS**

It will be done by applying Mann whitney U test ,Chi-square test

Protocol No change in the study procedure shall be affected without the mutual agreement of investigator, dentist and ethical committee approval. No hazardous materials will be used. The identity of patient generated in the study will be bounded in strict confidence. The remaining data will be available only to the investigator involved in the study and to the regulatory authorities. Break in the confidentiality is possible only after detail review by the investigator and with the permission of the ethical committee. Information will be disclosed to the concerned person/authority under special circumstances like severe unreported untoward reactions

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Patients with already placed implant 2) Patient requiring/indicating implant supported prosthesis.
1. Patient consenting for study.

Exclusion Criteria

1. Patient with poor oral hygiene.
1. Patient with para-functional habits 3) Patient with low osseointegrated implant.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
4) No. of colony seen -unsealed group	After 15 -20 days
1)Type of colony â€“ sealing gel group	After 15 -20 days
2)Type of colony â€“unsealed group	After 15 -20 days
3) No. of colony seen - sealing gel group	After 15 -20 days

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Pravara institute of medical sciences loni, district Ahmadnagar
🇮🇳
Ahmadnagar, MAHARASHTRA, India
Pravara institute of medical sciences loni, district Ahmadnagar
🇮🇳Ahmadnagar, MAHARASHTRA, India
Dr deepak vikhe
Principal investigator
9822811117
drdeepak_mvikhe@yahoo.com