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

• Sponsor: Hams Hamed Abdelrahman (Other)
• Overall Status: Completed
• CT.gov ID: NCT05101941
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 10
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Immediate Dental Implant; Tooth Exratction; Periapical; Infection	Procedure: Immediate dental implants	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluating the Osseointegration of Immediate Dental Implant Placed in the Presence of Chronic Inflammatory Periapical Lesions
• Actual Study Start Date: Dec 8, 2020
• Actual Primary Completion Date: Oct 7, 2021
• Actual Study Completion Date: Oct 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: immediate dental implants	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

Outcome Measures

Primary Outcome Measures

1. Change in Implant stability [immediately, at 3 months and 6 months]

   It will be measured by implant stability meter (Osstell™)

2. 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

1. 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).

2. 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)

3. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria Faculty of Dentistry	Alexandria		Egypt

Sponsors and Collaborators

• Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
• ClinicalTrials.gov Identifier: NCT05101941
• Other Study ID Numbers: Immediate implants_2020
• First Posted: Nov 1, 2021
• Last Update Posted: Nov 1, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 1, 2021