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

NCT07060859 | Completed

• 1 other identifier: DAG-RCT-2023
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Implant Stability and Osseointegration

Keywords

dexamethasone; ascorbic acid; β-sodium glycerophosphate; osseointegration; implant stability quotient; implant stability; resonance frequency analysis; osteogenic inducer; Immediate dental implants

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Study Arms (2)

Intervention (Test)

EXPERIMENTAL

Participants received a dental implant with the topical application of dexamethasone, ascorbic acid, and β-sodium glycerophosphate during surgery.

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

Control

NO INTERVENTION

Participants received a dental implant using the standard surgical procedure without any topical application.

Interventions

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.

Intervention (Test)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manar Ziad Foura-Matar: lead

Study Sites (1)

Al Azhar University - Faculty of Dentistry - Gaza

Gaza, Gaza Strip, Palestinian Territories

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This was a single-blind study in which participants were unaware of which implant site received the topical intervention. The care provider and investigator were aware of the allocation. Outcome assessors were masked to the assignment to ensure unbiased evaluation of implant stability measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dentist ( Implantologist)

Model Details: This study followed a split-mouth design, analyzed using a parallel assignment model at the implant level. Each participant received two dental implants: one implant served as the intervention site and received a topical application of dexamethasone, ascorbic acid, and β-sodium glycerophosphate, while the other implant served as the control site and received standard placement without any topical application. Both implants were placed during the same surgical session, allowing for intra-patient comparison under identical clinical and systemic conditions. Implant stability was assessed at multiple time points using resonance frequency analysis (RFA).

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: January 15, 2023
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)