NCT05101941

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

October 20, 2021

Last Update Submit

October 20, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Change in pain score

    within a week

  • Change in swelling status

    within a week

  • Change in Early Wound Healing Index

    at 2 weeks, 4 weeks, and 8 weeks

Study Arms (1)

immediate dental implants

EXPERIMENTAL
Procedure: Immediate dental implants

Interventions

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

immediate dental implants

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Smokers and alcoholics.
  • Medically compromised patients having uncontrolled diabetes or coagulation disorders.
  • Restorable teeth.
  • Periodontitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Infections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 1, 2021

Study Start

December 8, 2020

Primary Completion

October 7, 2021

Study Completion

October 7, 2021

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations