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

Not Applicable

Completed

• Conditions: Immediate Dental Implant; Tooth Exratction; Periapical; Infection
• Interventions: Procedure: Immediate dental implants

• Registration Number: NCT05101941
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

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

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

Study Timeline

• Study Start: 2020-12-08
• Status Verified: 2021-10
• Primary Completion: 2021-10-07
• Study Completion: 2021-10-07
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Last Update Submitted: 2021-10-20
• Study First Posted: 2021-11-01
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
immediate dental implants	Immediate dental implants	-

Primary Outcome Measures

Name	Time	Method
Change in Implant stability	immediately, at 3 months and 6 months	It will be measured by implant stability meter (Osstell™)
Change in peri implant radiolucency	immediately, and 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Early Wound Healing Index	at 2 weeks, 4 weeks, and 8 weeks	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).
Change in pain score	within a week	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).
Change in swelling status	within a week	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)

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt