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

Immediate Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05101941
• Other study ID #: Immediate implants_2020
• Status: Completed
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: October 7, 2021

Study information

• Verified date: October 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 7, 2021
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immediate Dental Implant
• Periapical; Infection

Intervention

Procedure:
• Immediate dental implants
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

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Implant stability	It will be measured by implant stability meter (Osstell™)	immediately, at 3 months and 6 months
Primary	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	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
Secondary	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
Secondary	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