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Completed

NCT Number: NCT07060859

Topical Dexamethasone, Ascorbic Acid, and BGP for Enhancing Implant Osseointegration

The goal of this clinical trial was to evaluate whether the topical application of a combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate could enhance implant osseointegration in adult dental implant patients. The main question it aimed to answer was:

Did the combined topical use of these agents improve implant stability during the healing phase?

Researchers compared intervention implants (which received the topical agents at the implant site) to control implants (which received standard placement without topical application) within the same participant, in order to assess differences in implant stability and osseointegration.

Participants:

Underwent dental implant surgery.

Received both the topical treatment and the standard procedure, applied to different implant sites.

Returned for follow-up visits, where implant stability was measured using resonance frequency analysis (RFA) at predefined time intervals.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Azhar University - Faculty of Dentistry - Gaza

Gaza, Gaza Strip, Palestinian Territories

About this study

This randomized clinical trial was conducted to investigate the effect of the topical application of a combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate on the osseointegration of dental implants. The rationale behind the study was based on existing evidence suggesting that these agents may enhance bone healing, reduce inflammation, and support mineralization when applied locally.

Each participant received two dental implants: one designated as the intervention site (treated with the topical combination of the three agents at the time of implant placement), and the other as the control site (placed without any topical application). This split-mouth design allowed intra-individual comparison, minimizing the influence of patient-related variability.

Implant stability was assessed using resonance frequency analysis (RFA) at four follow-up intervals to evaluate differences in osseointegration between the two sites. The study aimed to determine whether the adjunctive use of these agents could improve early implant stability, potentially contributing to more predictable outcomes in dental implantology.

No investigational drugs or devices were used beyond standard clinical tools. The study was approved by a local ethics committee, and informed consent was obtained from all participants prior to enrollment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provided a written informed consent prior to initiation of any study procedures.
  • Was able to understand and agrees to comply with planned study procedures and be available for all study visits.
  • Agreed to undergo cone beam computed tomography (CBCT) imaging.
  • Was a male or non-pregnant female, >/= to 18 years of age at the time of enrollment.
  • Was in good general health, free medical diseases.
  • Had two hopeless teeth for minimum required extraction for the purpose of implant-supported restorations.

Exclusion criteria

  • Was undergoing chronic treatment with any medication known to affect oral status and bone turnover.
  • Had a contraindication for surgical treatment.
  • Was suffering from a known psychological disorder.

Treatment and study plan

Topical Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate

Drug

A topical combination of dexamethasone (anti-inflammatory), ascorbic acid (antioxidant), and β-sodium glycerophosphate (mineralization support) was applied directly to the implant site during surgery. The intervention aimed to enhance early osseointegration by modulating local biological responses.

Primary outcomes

  1. Change in Implant Stability Measured by Implant Stability Quotient (ISQ) Using Resonance Frequency Analysis (RFA)

    Time frame: At baseline (day of surgery), 4 weeks, 8 weeks, and 16 weeks post-surgery

    Implant stability will be assessed using resonance frequency analysis (RFA), with results reported as Implant Stability Quotient (ISQ) values. The ISQ scale ranges from 1 (lowest stability) to 100 (highest stability). Higher ISQ values indicate better implant stability and osseointegration.

Sponsors and collaborators

Lead sponsor

Manar Ziad Foura-Matar

Other

Registry information

Official study title

The Influence of The Topical Combined Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate on Implant Osseointegration: A Randomized Clinical Trial

Acronym: DAG

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2025
Registry last updated
Jul 15, 2025

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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