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Completed

NCT Number: NCT05101941

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

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

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Key information

Conditions

Immediate Dental Implant Infections Periapical; Infection Tooth Exratction

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immediate dental implants

Procedure

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

Primary outcomes

  1. Change in Implant stability

    Time frame: immediately, at 3 months and 6 months

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

  2. Change in peri implant radiolucency

    Time frame: 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 outcomes

  1. Change in pain score

    Time frame: 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

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2021
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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