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Completed

NCT Number: NCT03090282

Subgingival Microbiota Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Periodontitis Patients

The investigators planed to observe the microbiome of an aggressive periodontitis patient, during mechanical treatment, surgery(if indicated) and implant placement. The investigators designed to observe the changes after mechanical treatment.Then, the investigators will compare the sub-mucosa microbiome of implant and the subgingival community. The investigators expected a different community after treatment, and there could be similarity between implant and nature teeth.

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Key information

Conditions

Aggressive Periodontitis, Generalized Aggressive Periodontitis Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking university hospital of stomatology

Beijing, Beijing Municipality, 100081, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects were between 18-35 years old and diagnosed with generalized aggressive periodontitis (GAgP) according to the 1999 International Classification of Periodontal Diseases (Armitage 1999);
  • At least 20 teeth in the first appointment and at least 3 teeth(other than first molars and central incisors)with a probing depth(PD) ≥ 6mm, clinical attachment level (CAL)≥5mm;
  • The clinical diagnosis was confirmed by evidence of inter-proximal bone loss on full-mouth periapical radiographs;
  • Family history of aggressive periodontitis.

Exclusion criteria

  • Uncontrolled systemic conditions including diabetes and hypertension;
  • Pregnant or lactating;
  • Smoking;
  • Received periodontal treatment within the previous 6 months or antibiotic medication during the previous 3 months.

Treatment and study plan

mechanical treatment(mainly scaling and root planing), periodontal surgery(if indicated), implant placement.

Procedure

The investigators shall follow the regular procedure to these patients.

Primary outcomes

  1. changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community)

    Time frame: Baseline, 6 weeks after mechanical treatment

    the diversity of subgingival community before and after mechanical treatment

  2. changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community)

    Time frame: before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.

    the diversity of submucosa community before and after implatation

  3. changes of prevalence and abundance of OTUs

    Time frame: Baseline, 6 weeks after mechanical treatment

    compute and compare the prevalence and abundance of OTUs

  4. changes of prevalence and abundance of OTUs

    Time frame: before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.

    compute and compare the prevalence and abundance of OTUs

Secondary outcomes

  1. changes of bleeding index

    Time frame: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.

    bleeding index after probing

  2. changes of probing depth

    Time frame: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.

    probing depth of indicated sites

  3. clinical attachment loss

    Time frame: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.

    by probe, the distance between CEJ and gingival sulcus

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

Subgingival Microbiome Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Aggressive Periodontitis Patients

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Mar 24, 2017
Registry last updated
Mar 29, 2023

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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