AzTrials
AzTrials

Dental Implant Failure NosNCT06521203

Periapical Lesions and Immediate Implants

An observational study of Dental Implant Failure Nos and Periapical Granuloma, run by Akdeniz University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this case-control study is to evaluate the success and survival rates of dental implants immediately placed into extraction sites in the presence of periapical pathology. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
25 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2016to 1 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The present study included patients, who underwent immediate implant placement following extraction of a tooth with periapical pathology.

Who may be able to join

  • To have 1 or more teeth with a chronic periapical lesion that requiring extraction.
  • The chronic periapical lesion should be determined as an asymptomatic periapical radiolucency with a diameter ranging between 4 and 8 mm.
  • The patients undergoing tooth extraction must have been treated with an immediate implant placement procedure.
  • At the time of extraction and implant placement, the neighboring teeth must have had healthy periodontal and periapical status.

Who cannot join

  • Age younger than 18 years
  • Any systemic disease or medication that might compromise osseointegration, bone or soft tissue healing
  • Smoking
  • Purulent exudate during the extraction
  • Severe deficiency of soft and/or hard tissue in implant region
  • Pregnancy
Show all 9Show fewer
  • Lactation
  • History of chemotherapy or radiotherapy
  • Severe parafunctional habits

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Akdeniz University

    Antalya, 07070

Other trials in Turkey (Türkiye)

About this study

Official title: Immediate Implant Placement in Sites With Chronic Periapical Lesions

The aim of this case-control study is to evaluate the success and survival rates of dental implants immediately placed into extraction sites in the presence of periapical pathology.

The main questions it aims to answer are:

What were the survival and success rates of implants immediately placed into extraction sockets of teeth with chronic periodical lesions.

A retrospective analysis was performed based on the evaluation of certain clinical and radiographic parameters 12 months after prosthetic function of these implants.

Read the detailed description

In 25 patients (13 men, 12 women), certain clinical and radiological parameters were retrospectively evaluated with particular interest in survival and success rates of the implants (total of 30 implants, 21 in the maxilla, 9 in the mandible) placed immediately to extraction sites of teeth with chronic periapical lesions. These parameters included mobility and the presence or absence of chronic pain, probing depth, gingival index, radiographic measurements of crestal bone loss on mesial and distal aspects of the implants.

Keywords
Dental implant, Immediate dental implant, Osseointegrated implants, Osseointegration, Periapical granuloma, Tooth extraction
Medical subject headings
Periapical Granuloma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival of the implants

    Pain on palpation, percussion, or function (Yes/No) Implant mobility (Yes/No) Radiographic crestal bone loss (<4.0 mm) Absence of pain and mobility and crestal bone loss up to 4 mm were regarded as survive.

    Measured: Immediately after the implant placement and after 12 months of prosthesis function.

  2. Success of the implants

    Pain on palpation, percussion, or function (Yes/No) Implant mobility (Yes/No) Radiographic crestal bone loss (<2mm) Gingival index score (1-2-3) Probing depth (mm) Absence of pain and mobility, crestal bone loss <2mm, GI score less than 2, probing depth <5mm were regarded as success.

    Measured: Immediately after the implant placement and after 12 months of prosthesis function.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2024
  2. Study start1 Jan 2016
  3. Primary completion1 Jan 2018
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06521203
Sponsor's protocol ID
20022019/188
Status last verified
Jul 2024
First submitted
17 Jul 2024
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4.

    PubMed 6809663

  • Colak S, Demirsoy MS. Retrospective analysis of dental implants immediately placed in extraction sockets with periapical pathology: immediate implant placement in infected areas. BMC Oral Health. 2023 May 18;23(1):304. doi: 10.1186/s12903-023-02986-0.

    PubMed 37208620

  • Blanco J, Carral C, Argibay O, Linares A. Implant placement in fresh extraction sockets. Periodontol 2000. 2019 Feb;79(1):151-167. doi: 10.1111/prd.12253.

    PubMed 30892772

  • Koh RU, Rudek I, Wang HL. Immediate implant placement: positives and negatives. Implant Dent. 2010 Apr;19(2):98-108. doi: 10.1097/ID.0b013e3181d47eaf.

    PubMed 20386212

  • de Carvalho BC, de Carvalho EM, Consani RL. Flapless single-tooth immediate implant placement. Int J Oral Maxillofac Implants. 2013 May-Jun;28(3):783-9. doi: 10.11607/jomi.2140.

    PubMed 23748309

  • Gao Y, Luo D, Yuan M, Yang Y, Yang J. Immediate implant placement in single mandibular molar with chronic periapical periodontitis. J Stomatol Oral Maxillofac Surg. 2023 Dec;124(6S):101545. doi: 10.1016/j.jormas.2023.101545. Epub 2023 Jun 29.

    PubMed 37390904

  • Lang NP, Pun L, Lau KY, Li KY, Wong MC. A systematic review on survival and success rates of implants placed immediately into fresh extraction sockets after at least 1 year. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:39-66. doi: 10.1111/j.1600-0501.2011.02372.x.

    PubMed 22211305

  • Waasdorp JA, Evian CI, Mandracchia M. Immediate placement of implants into infected sites: a systematic review of the literature. J Periodontol. 2010 Jun;81(6):801-8. doi: 10.1902/jop.2010.090706.

    PubMed 20192616

  • Alsaadi G, Quirynen M, Komarek A, van Steenberghe D. Impact of local and systemic factors on the incidence of oral implant failures, up to abutment connection. J Clin Periodontol. 2007 Jul;34(7):610-7. doi: 10.1111/j.1600-051X.2007.01077.x. Epub 2007 Apr 13.

    PubMed 17433044

  • Truninger TC, Philipp AO, Siegenthaler DW, Roos M, Hammerle CH, Jung RE. A prospective, controlled clinical trial evaluating the clinical and radiological outcome after 3 years of immediately placed implants in sockets exhibiting periapical pathology. Clin Oral Implants Res. 2011 Jan;22(1):20-7. doi: 10.1111/j.1600-0501.2010.01973.x.

    PubMed 20678132

  • von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ. 2007 Oct 20;335(7624):806-8. doi: 10.1136/bmj.39335.541782.AD.

    PubMed 17947786

  • Misch CE, Perel ML, Wang HL, Sammartino G, Galindo-Moreno P, Trisi P, Steigmann M, Rebaudi A, Palti A, Pikos MA, Schwartz-Arad D, Choukroun J, Gutierrez-Perez JL, Marenzi G, Valavanis DK. Implant success, survival, and failure: the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Implant Dent. 2008 Mar;17(1):5-15. doi: 10.1097/ID.0b013e3181676059.

    PubMed 18332753

  • Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

    PubMed 1058834

  • Suzuki JB, Misch CE. Periodontal and maintenance complications. In: Resnik RR, Misch CE, eds. Misch's Avoiding Complications in Oral Implantology. Elsevier; 2017:771-826.

  • Maheshwari R, Punia V, Khandelwal M, Sharma V, Malot S, Porwal A. Implant failure and management: A review. IJADS. 2018;4:293-8.

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Implant Failure Nos and Periapical Granuloma, run by Akdeniz University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival of the implants (time frame: Immediately after the implant placement and after 12 months of prosthesis function.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06521203, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.

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