Immediate Dental Implant Placed in the Presence of Chronic Inflammatory Periapical Lesions

Study Overview
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Brief Summary
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Compromised teeth with periapical pathologies are removed before dental implant placement and sockets are left to heal. Some clinicians began to immediately place dental implants in fresh extraction sockets associated with chronic inflammatory periapical lesions and these studies revealed high success rates

Detailed Description
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12 implants will be immediately placed in sockets associated with chronic periapical granuloma. Clinical (Wound healing, Pain, swelling, implant stability) and radiographic parameters (Peri-implant radiolucency) will be evaluated

Official Title
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Evaluating the Osseointegration of Immediate Dental Implant Placed in the Presence of Chronic Inflammatory Periapical Lesions

Conditions
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Immediate Dental Implant, Tooth Exratction, Periapical; Infection

Intervention / Treatment
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* Procedure: Immediate dental implants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients ranging from 18 to 45 years with no gender predilection agreed to come for minimum follow-up visits for 6 months. Adequate bone beyond teeth apices without jeopardizing any anatomical structure. Single rooted mandibular teeth with chronic inflammatory periapical lesions represented as periapical radiolucency, pulp necrosis, sinus tract, failed RCT. Exclusion Criteria: Smokers and alcoholics. Medically compromised patients having uncontrolled diabetes or coagulation disorders. Restorable teeth. Periodontitis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate dental implants<br> | Procedure: Immediate dental implants<br>* Implants will be immediately placed in sockets associated with chronic periapical granuloma Extraction of non-restorable Teeth with periapical granuloma and socket debridement will be done then implants will be placed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Implant stability | It will be measured by implant stability meter (Osstell™) | immediately, at 3 months and 6 months | 
| Change in peri implant radiolucency | Immediate post-operative and after 6 months CBCT will be requested in order to compare the dimension of the periapical lesion in millimeters using OnDemand system. | immediately, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain score | It will be recorded daily for the first week through a 10-point Visual Analogue Scale (VAS) from 0 to 10 (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe). | within a week | 
| Change in swelling status | It will be recorded daily for the first week through a 10-point scale with 4 parameters will be used. none (no swelling), light (intraoral, localized to the treated area), moderate (extraoral swelling localized to the treated area), and severe (extraoral swelling extending beyond the treated area) | within a week | 
| Change in Early Wound Healing Index | Using Early Wound Healing Index (EHI), it will be evaluated across weeks 2, 4 and 8. (EHI; 1: complete flap closure-no fibrin line; 2: complete flap closure-fine fibrin line; 3: complete flap closure-fibrin clot; 4: incomplete flap closure-partial necrosis; 5: incomplete flap closure-complete necrosis). | at 2 weeks, 4 weeks, and 8 weeks |