NCT07608523

Brief Summary

This study evaluates and compares marginal bone level changes around dental implants with two different surface characteristics in patients with a history of periodontitis. Participants will receive dental implants and will be followed up for one year to assess bone level changes around the implants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration 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

April 30, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
Last Updated

June 16, 2026

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

May 20, 2026

Last Update Submit

June 13, 2026

Conditions

PeriodontitisDental ImplantsMarginal Bone LossPeriodontal Probing DepthGingival Inflammation

Keywords

SLA implantPlasma spraying implantPeri-implant bonePeriodontitis patientsImplant surfaceProbing DepthGingival Index

Outcome Measures

Primary Outcomes (1)

  • Marginal Bone Level

    Radiographic assessment of marginal bone level changes around dental implants measured in millimeters using Cone Beam Computed Tomography (CBCT)

    Baseline, 3 months, 6 months, and 12 months after implant placement

Secondary Outcomes (2)

  • Probing Depth

    Baseline, 3 months, 6 months, and 12 months

  • Gingival Index

    Baseline, 3 months, 6 months, and 12 months

Study Arms (4)

Group I - Periodontitis SLA

EXPERIMENTAL

15 periodontitis patients receiving SLA surface implants

Device: SLA Dental Implant

Group II - Periodontitis Plasma

EXPERIMENTAL

15 periodontitis patients receiving plasma spraying surface treated implants

Device: Plasma Spraying Dental Implant

Group III - Healthy SLA

ACTIVE COMPARATOR

5 periodontally healthy patients receiving SLA surface implants

Device: SLA Dental Implant

Group IV - Healthy Plasma

ACTIVE COMPARATOR

5 periodontally healthy patients receiving plasma spraying surface treated implants

Device: Plasma Spraying Dental Implant

Interventions

SLA Dental ImplantDEVICE

Sandblasted large-grit corundum and acid-etched (SLA) surface dental implant

Group I - Periodontitis SLAGroup III - Healthy SLA
Plasma Spraying Dental ImplantDEVICE

Plasma spraying surface treated dental implant

Group II - Periodontitis PlasmaGroup IV - Healthy Plasma

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranged from 35 to 55 years old, with a history of periodontitis
  • Presence of at least one edentulous space
  • Presence of adequate bone volume to place implants and achieves primary implant stability without the need for bone reconstructive approaches
  • Absence of systemic diseases

You may not qualify if:

  • Presence of para-functional habits
  • Chronic smokers or former smokers
  • Pregnancy and lactation
  • Any patient who is not willing to follow our treatment protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

PeriodontitisGingivitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Officials

  • Osama Sayed EL-Shall, Professor

    Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egypt

    PRINCIPAL INVESTIGATOR

  • Lobna Mohamed Abd-ELaziz, Associate Professor

    Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Participants will be divided into four groups based on implant surface type and periodontal status: Group I: 15 periodontitis patients receiving sandblasted large-grit corundum and acid-etched (SLA) surface implants. Group II: 15 periodontitis patients receiving plasma spraying surface treated implants. Group III: 5 periodontally healthy patients receiving sandblasted large-grit corundum and acid-etched (SLA) surface implants. Group IV: 5 periodontally healthy patients receiving plasma spraying surface treated implants. All groups will be followed up for 12 months to assess marginal bone level changes radiographically.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Howida Sabry Saad EL-Deen Ali Rashwan

Study Record Dates

First Submitted

May 20, 2026

First Posted

May 27, 2026

Study Start

April 30, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2026

Last Updated

June 16, 2026

Record last verified: 2023-04

Locations

EG(1)