Osseointegrated Dental ImplantationPhase 4NCT04694300
OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients
A Phase 4 study testing Naproxen, Acetaminophen and Tramadol in people with Osseointegrated Dental Implantation and Pain, Acute, run by Hersh, Elliot V., DMD, MS, PhD at 1 site in United States.
Trial summary
This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osseointegrated Dental Implantation, Pain, Acute
- What is being tested?
- Naproxen, Acetaminophen and Tramadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2021to 28 Aug 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject requires surgical placement of one or two (adjacent) dental implants
- Ability to read and sign informed consent
- Males and females for 18-75 years of age
- Non-smokers
- Negative urine drug screen
Who cannot join
- Advanced periodontal disease (>20% Clinical Attachment Loss >20% radiographic bone loss)
- History of bisphosphonate usage
- Medical history or medical condition that makes any of the study medications (naproxen sodium, acetaminophen, tramadol, etc.) inappropriate treatment options including any scheduled or recent cardiac procedures (within 6 months), a history of GI ulcers, liver or kidney disease, and anticoagulant or lithium intake.
- History of an allergic reaction to any pain reliever/fever reducer
- Contraindication to opioid use
- Positive urine drug screen for drugs of abuse unless on stable doses of a non-analgesic drug for a legitimate medical purpose
Show all 11Show fewer
- Pregnancy - A urine pregnancy test will be performed immediately before the scheduled surgery on all women of child-bearing potential
- Local or systemic diseases that affects wound healing and inflammatory biomarkers (diabetes, autoimmune (rheumatoid arthritis), or inflammatory disorders - osteoarthritis is allowed).
- Smokers on this pilot study because it can affect levels of inflammatory biomarkers - a urine cotinine test will be performed immediately prior to the scheduled surgery on all subjects even if participant denies smoking history
- History of systemic steroid use over 2 weeks within last 2 years.
- Poor oral hygiene on a non-compliant individual.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, 19104-6030
About this study
Official title: Demonstration of OTC Naproxen Sodium's (Aleve's) Anti-inflammatory Action in Dental Implant Surgery Patients
This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
Read the detailed description
Placement of dental implants is a frequently performed outpatient surgical procedure, with United States dentists currently placing implants in approximately 500,000 patients per year.This procedure has become the gold standard for replacing missing teeth due to its high level of predictability and patient acceptance, with long-term success rates greater than 95%. Thus, the number of patients opting for this procedure over dentures and fixed bridges continues to increase. In the period between 1999 and 2000 only 0.7% of the USA population had missing teeth with implants in contrast to 5.7% between 2015 and 2016 It is estimated that by 2026, if the current pace of dental implant placement continues, approximately 17% of the population will have dental implants.
Dental implant surgery involves the incision of gingival tissue to expose the underlying bone, followed by the creation of a precise bony cavity where the implant will be placed using a specialized surgical drill, and lastly the screwing of the implant into bone using a specialized handpiece Thus, it is not surprising that post-surgical pain is a common sequela following dental implant surgery. Patients often experience post-surgical pain for several days after the placement of one to three dental implants, but at a pain intensity level that is generally less than that of dental impaction surgery. This post-surgical pain is inflammatory in nature; thus, NSAIDs have demonstrated efficacy and are the preferred analgesics in this patient population. Postoperative administration of intranasal ketorolac (SPRIX®) and oral acetaminophen 325 mg plus codeine 30 mg have both demonstrated efficacy.
The soft tissue and bony trauma associated with dental implant surgery upregulates inflammatory mediators both locally and systemically. Elevated levels of interleukin (IL)-6, IL-8, and macrophage inflammatory protein (MIP)-1β have been observed in gingival crevicular fluid (GCF) from the implant site and the adjacent teeth one week after surgery. Prostaglandin E2 has been measured in the GCF of teeth surrounding implant sites employing similar methodology. Additionally, standard periodontal flap and bony recontouring surgery, which shares many similarities to dental implant surgery, induces an upregulation in immunoreactive prostaglandin E2 and leukotriene B4 levels at the surgical site. Dental implant surgery also increases cytokine levels in plasma, indicative of a systemic inflammatory response. Thus, in addition to being a model to study the efficacy and tolerability of OTC analgesics, dental implant surgery also appears to be an excellent model to study the anti-inflammatory properties of NSAIDs such as naproxen sodium.
Therefore, the investigators propose to initiate a double-blind, pilot study to evaluate the anti-inflammatory and analgesic effects of an OTC regimen of naproxen sodium versus acetaminophen in dental implant surgery patients. Notably, the vast majority of these patients are over the age of 45, a patient demographic that is rarely captured in postsurgical dental pain studies. Compared to dental impaction surgery patients, implant surgery patients possess more comorbidities such as hypertension, hyperlipidemia and hyperglycemia Thus, while dental impaction patients are typically on few if any drugs, polypharmacy is more of the norm in dental implant surgery patients. Performing a controlled study with OTC naproxen sodium in this population will provide the opportunity to confirm that its short-term use is generally safe and effective in these older, more medically complex patients. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
- Conditions
- Osseointegrated Dental Implantation, Pain, Acute
- Being tested
- Naproxen, Acetaminophen, Tramadol
- Keywords
- Naproxen sodium, Acetaminophen, Postsurgical dental pain, Prostaglandins, Interleukins
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Also called Aleve
440 mg by mouth immediately after completion of implant surgery followed by 220 mg 12 hours later.
Then 220 mg every 8 hours for the next two days.
AcetaminophenDrug
Also called Extra Strength Tylenol
1000 mg by mouth immediately after the completion of implant surgery followed by 1000 mg every 6 hours for 3 days after surgery with a maximum daily dose of 3000 mg.
TramadolDrug
Also called Ultram
50 mg by mouth every 6 hours as needed for pain
| Study group | Role | What they receive |
|---|---|---|
| Naproxen sodium | Experimental | Naproxen sodium 440 mg followed by naproxen sodium 220 mg q 8h (max 660 mg/day) Receives: Drug: Naproxen; Drug: Tramadol |
| Acetaminophen | Active comparator | Acetaminophen 1000 mg followed by acetaminophen 1000 mg q 6h (max 3000 mg/day according to Tylenol package insert) Receives: Drug: Acetaminophen; Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Scores on Numeric Pain Intensity Scale 0-6 Hours
Median maximum pain intensity scores where 0 = no pain and 10 = worst possible pain
Measured: Up to 6 hours
Pain Intensity Scores From 6 Through 72 Hours (Multi-dose Phase)
Pain intensity scores where 0 = no pain and 10 = worst possible pain
Measured: 6-72 hours Post initial Dose
Peak Plasma IL-6 Concentrations
Plasma IL-6 concentrations 6 hours after treatment measured by ELISA
Measured: 6 hours
Plasma IL-6 Change From Baseline
Percent change in plasma IL-6 levels at 6 hours after treatment relative to baseline
Measured: 6 hours post dose
Secondary outcomes (6)
Rescue Analgesic Use
Number of patients requiring opioid rescue medication (tramadol) during inpatient phase (0-6 hours) in each treatment group
Measured: 0-6 hours
Rescue Medication Use Outpatient Phase (6-72 Hours)
Number of patients requiring opioid rescue medication during outpatient phase in both treatment groups
Measured: 6-72 hours
Peak GCF IL-1β Levels
Levels of IL-1β in gingival crevicular fluid measured at 24 hours after treatment
Measured: 24 hours post-dose
COX-1 Activity Percent of Baseline (Pre-surgery)
Cyclooxygenase (COX)-1 activity was evaluated ex vivo by quantifying serum thromboxane B2 levels
Measured: 6 hours post dose
COX-2 Activity
COX-2 activity was evaluated ex vivo by quantifying plasma prostaglandin (PG)E2 levels following lipopolysaccharide (LPS) stimulation in whole blood,
Measured: 6 hours post-dose
Peak GCF IL-8levels
Levels of IL-8 in gingival crevicular fluid measured at 24 hours after treatment
Measured: 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start7 Feb 2021
- Primary completion28 Aug 2022
- Study completion28 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Osseointegrated Dental ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, randomized, active-controlled, two arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hersh, Elliot V., DMD, MS, PhD
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Elliot V Hersh, DMD, MS, PhD, Principal investigator, University of PennsylvaniaKatherine N Theken, PharmD, PhD, Principal investigator, University of Pennsylvania School of Dental Medicine and Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694300
- Sponsor's protocol ID
- 844440
- Other IDs
- IIR
- Status last verified
- May 2024
- First submitted
- 31 Dec 2020
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared. This is a pilot, exploratory study.
Publications
Moore PA, Hersh EV. Combining ibuprofen and acetaminophen for acute pain management after third-molar extractions: translating clinical research to dental practice. J Am Dent Assoc. 2013 Aug;144(8):898-908. doi: 10.14219/jada.archive.2013.0207.
PubMed 23904576Hersh EV, Moore PA, Grosser T, Polomano RC, Farrar JT, Saraghi M, Juska SA, Mitchell CH, Theken KN. Nonsteroidal Anti-Inflammatory Drugs and Opioids in Postsurgical Dental Pain. J Dent Res. 2020 Jul;99(7):777-786. doi: 10.1177/0022034520914254. Epub 2020 Apr 14.
PubMed 32286125Deeb GR, Deeb JG, Agarwal V, Laskin DM. Use of transalveolar sutures to maintain vestibular depth and manipulate keratinized tissue following alveolar ridge reduction and implant placement for mandibular prosthesis. J Oral Maxillofac Surg. 2015 Jan;73(1):48-52. doi: 10.1016/j.joms.2014.07.022. Epub 2014 Jul 30.
PubMed 25315314Schmitt A, Zarb GA. The longitudinal clinical effectiveness of osseointegrated dental implants for single-tooth replacement. Int J Prosthodont. 1993 Mar-Apr;6(2):197-202.
PubMed 8329098Zarb GA, Schmitt A. The longitudinal clinical effectiveness of osseointegrated dental implants in posterior partially edentulous patients. Int J Prosthodont. 1993 Mar-Apr;6(2):189-96.
PubMed 8329097Elani HW, Starr JR, Da Silva JD, Gallucci GO. Trends in Dental Implant Use in the U.S., 1999-2016, and Projections to 2026. J Dent Res. 2018 Dec;97(13):1424-1430. doi: 10.1177/0022034518792567. Epub 2018 Aug 3.
PubMed 30075090Bockow R, Korostoff J, Pinto A, Hutcheson M, Secreto SA, Bodner L, Hersh EV. Characterization and treatment of postsurgical dental implant pain employing intranasal ketorolac. Compend Contin Educ Dent. 2013 Sep;34(8):570-6.
PubMed 24564610Alissa R, Sakka S, Oliver R, Horner K, Esposito M, Worthington HV, Coulthard P. Influence of ibuprofen on bone healing around dental implants: a randomised double-blind placebo-controlled clinical study. Eur J Oral Implantol. 2009 Autumn;2(3):185-99.
PubMed 20467629Hashem AA, Claffey NM, O'Connell B. Pain and anxiety following the placement of dental implants. Int J Oral Maxillofac Implants. 2006 Nov-Dec;21(6):943-50.
PubMed 17190305Al-Khabbaz AK, Griffin TJ, Al-Shammari KF. Assessment of pain associated with the surgical placement of dental implants. J Periodontol. 2007 Feb;78(2):239-46. doi: 10.1902/jop.2007.060032.
PubMed 17274712Samieirad S, Afrasiabi H, Tohidi E, Qolizade M, Shaban B, Hashemipour MA, Doaltian Shirvan I. Evaluation of caffeine versus codeine for pain and swelling management after implant surgeries: A triple blind clinical trial. J Craniomaxillofac Surg. 2017 Oct;45(10):1614-1621. doi: 10.1016/j.jcms.2017.06.014. Epub 2017 Jul 5.
PubMed 28864284Emecen-Huja P, Eubank TD, Shapiro V, Yildiz V, Tatakis DN, Leblebicioglu B. Peri-implant versus periodontal wound healing. J Clin Periodontol. 2013 Aug;40(8):816-24. doi: 10.1111/jcpe.12127. Epub 2013 Jun 18.
PubMed 23772674Aboyoussef H, Carter C, Jandinski JJ, Panagakos FS. Detection of prostaglandin E2 and matrix metalloproteinases in implant crevicular fluid. Int J Oral Maxillofac Implants. 1998 Sep-Oct;13(5):689-96.
PubMed 9796154O'Brien TP, Roszkowski MT, Wolff LF, Hinrichs JE, Hargreaves KM. Effect of a non-steroidal anti-inflammatory drug on tissue levels of immunoreactive prostaglandin E2, immunoreactive leukotriene, and pain after periodontal surgery. J Periodontol. 1996 Dec;67(12):1307-16. doi: 10.1902/jop.1996.67.12.1307.
PubMed 8997678Li S, Yang Y, Yu C, Yao Y, Wu Y, Qian L, Cheung CW. Dexmedetomidine Analgesia Effects in Patients Undergoing Dental Implant Surgery and Its Impact on Postoperative Inflammatory and Oxidative Stress. Oxid Med Cell Longev. 2015;2015:186736. doi: 10.1155/2015/186736. Epub 2015 Jun 15.
PubMed 26171113
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of OTC Naproxen Sodium's (Aleve's) Anti-inflammatory Action in Dental Implant Surgery Patients
- ClinicalTrials.gov ID
- NCT04694300
- Acronym / sponsor ID
- 844440
- Conditions
- Osseointegrated Dental Implantation, Pain, Acute
- Keywords
- Naproxen sodium, Acetaminophen, Postsurgical dental pain, Prostaglandins, Interleukins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hersh, Elliot V., DMD, MS, PhD
- Collaborators
- University of Pennsylvania
- Study start
- 7 Feb 2021 (actual)
- Primary completion
- 28 Aug 2022 (actual)
- Study completion
- 28 Aug 2022 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
Detailed description
Placement of dental implants is a frequently performed outpatient surgical procedure, with United States dentists currently placing implants in approximately 500,000 patients per year.This procedure has become the gold standard for replacing missing teeth due to its high level of predictability and patient acceptance, with long-term success rates greater than 95%. Thus, the number of patients opting for this procedure over dentures and fixed bridges continues to increase. In the period between 1999 and 2000 only 0.7% of the USA population had missing teeth with implants in contrast to 5.7% between 2015 and 2016 It is estimated that by 2026, if the current pace of dental implant placement continues, approximately 17% of the population will have dental implants.
Dental implant surgery involves the incision of gingival tissue to expose the underlying bone, followed by the creation of a precise bony cavity where the implant will be placed using a specialized surgical drill, and lastly the screwing of the implant into bone using a specialized handpiece Thus, it is not surprising that post-surgical pain is a common sequela following dental implant surgery. Patients often experience post-surgical pain for several days after the placement of one to three dental implants, but at a pain intensity level that is generally less than that of dental impaction surgery. This post-surgical pain is inflammatory in nature; thus, NSAIDs have demonstrated efficacy and are the preferred analgesics in this patient population. Postoperative administration of intranasal ketorolac (SPRIX®) and oral acetaminophen 325 mg plus codeine 30 mg have both demonstrated efficacy.
The soft tissue and bony trauma associated with dental implant surgery upregulates inflammatory mediators both locally and systemically. Elevated levels of interleukin (IL)-6, IL-8, and macrophage inflammatory protein (MIP)-1β have been observed in gingival crevicular fluid (GCF) from the implant site and the adjacent teeth one week after surgery. Prostaglandin E2 has been measured in the GCF of teeth surrounding implant sites employing similar methodology. Additionally, standard periodontal flap and bony recontouring surgery, which shares many similarities to dental implant surgery, induces an upregulation in immunoreactive prostaglandin E2 and leukotriene B4 levels at the surgical site. Dental implant surgery also increases cytokine levels in plasma, indicative of a systemic inflammatory response. Thus, in addition to being a model to study the efficacy and tolerability of OTC analgesics, dental implant surgery also appears to be an excellent model to study the anti-inflammatory properties of NSAIDs such as naproxen sodium.
Therefore, the investigators propose to initiate a double-blind, pilot study to evaluate the anti-inflammatory and analgesic effects of an OTC regimen of naproxen sodium versus acetaminophen in dental implant surgery patients. Notably, the vast majority of these patients are over the age of 45, a patient demographic that is rarely captured in postsurgical dental pain studies. Compared to dental impaction surgery patients, implant surgery patients possess more comorbidities such as hypertension, hyperlipidemia and hyperglycemia Thus, while dental impaction patients are typically on few if any drugs, polypharmacy is more of the norm in dental implant surgery patients. Performing a controlled study with OTC naproxen sodium in this population will provide the opportunity to confirm that its short-term use is generally safe and effective in these older, more medically complex patients. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, randomized, active-controlled, two arms
| Arm | Type | Receives |
|---|---|---|
| Naproxen sodium | Experimental | Drug: Naproxen, Drug: TramadolNaproxen sodium 440 mg followed by naproxen sodium 220 mg q 8h (max 660 mg/day) |
| Acetaminophen | Active comparator | Drug: Acetaminophen, Drug: TramadolAcetaminophen 1000 mg followed by acetaminophen 1000 mg q 6h (max 3000 mg/day according to Tylenol package insert) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject requires surgical placement of one or two (adjacent) dental implants
- Ability to read and sign informed consent
- Males and females for 18-75 years of age
- Non-smokers
- Negative urine drug screen
Key exclusion criteria (11 listed)
- Advanced periodontal disease (>20% Clinical Attachment Loss >20% radiographic bone loss)
- History of bisphosphonate usage
- Medical history or medical condition that makes any of the study medications (naproxen sodium, acetaminophen, tramadol, etc.) inappropriate treatment options including any scheduled or recent cardiac procedures (within 6 months), a history of GI ulcers, liver or kidney disease, and anticoagulant or lithium intake.
- History of an allergic reaction to any pain reliever/fever reducer
- Contraindication to opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaproxenAlso: Aleve440 mg by mouth immediately after completion of implant surgery followed by 220 mg 12 hours later. Then 220 mg every 8 hours for the next two days. | Drug | Naproxen sodium |
| AcetaminophenAlso: Extra Strength Tylenol1000 mg by mouth immediately after the completion of implant surgery followed by 1000 mg every 6 hours for 3 days after surgery with a maximum daily dose of 3000 mg. | Drug | Acetaminophen |
| TramadolAlso: Ultram50 mg by mouth every 6 hours as needed for pain | Drug | Acetaminophen, Naproxen sodium |
Primary outcome
Pain Intensity Scores on Numeric Pain Intensity Scale 0-6 Hours
Time frame: Up to 6 hours
Median maximum pain intensity scores where 0 = no pain and 10 = worst possible pain
Pain Intensity Scores From 6 Through 72 Hours (Multi-dose Phase)
Time frame: 6-72 hours Post initial Dose
Pain intensity scores where 0 = no pain and 10 = worst possible pain
Peak Plasma IL-6 Concentrations
Time frame: 6 hours
Plasma IL-6 concentrations 6 hours after treatment measured by ELISA
Plasma IL-6 Change From Baseline
Time frame: 6 hours post dose
Percent change in plasma IL-6 levels at 6 hours after treatment relative to baseline
6 secondary outcomes
Rescue Analgesic Use
Time frame: 0-6 hours
Rescue Medication Use Outpatient Phase (6-72 Hours)
Time frame: 6-72 hours
Peak GCF IL-1β Levels
Time frame: 24 hours post-dose
COX-1 Activity Percent of Baseline (Pre-surgery)
Time frame: 6 hours post dose
COX-2 Activity
Time frame: 6 hours post-dose
Peak GCF IL-8levels
Time frame: 24 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23904576Moore PA, Hersh EV. Combining ibuprofen and acetaminophen for acute pain management after third-molar extractions: translating clinical research to dental practice. J Am Dent Assoc. 2013 Aug;144(8):898-908. doi: 10.14219/jada.archive.2013.0207.
- Background: PubMed 32286125Hersh EV, Moore PA, Grosser T, Polomano RC, Farrar JT, Saraghi M, Juska SA, Mitchell CH, Theken KN. Nonsteroidal Anti-Inflammatory Drugs and Opioids in Postsurgical Dental Pain. J Dent Res. 2020 Jul;99(7):777-786. doi: 10.1177/0022034520914254. Epub 2020 Apr 14.
- Background: PubMed 25315314Deeb GR, Deeb JG, Agarwal V, Laskin DM. Use of transalveolar sutures to maintain vestibular depth and manipulate keratinized tissue following alveolar ridge reduction and implant placement for mandibular prosthesis. J Oral Maxillofac Surg. 2015 Jan;73(1):48-52. doi: 10.1016/j.joms.2014.07.022. Epub 2014 Jul 30.
- Background: PubMed 8329098Schmitt A, Zarb GA. The longitudinal clinical effectiveness of osseointegrated dental implants for single-tooth replacement. Int J Prosthodont. 1993 Mar-Apr;6(2):197-202.
- Background: PubMed 8329097Zarb GA, Schmitt A. The longitudinal clinical effectiveness of osseointegrated dental implants in posterior partially edentulous patients. Int J Prosthodont. 1993 Mar-Apr;6(2):189-96.
- Background: PubMed 30075090Elani HW, Starr JR, Da Silva JD, Gallucci GO. Trends in Dental Implant Use in the U.S., 1999-2016, and Projections to 2026. J Dent Res. 2018 Dec;97(13):1424-1430. doi: 10.1177/0022034518792567. Epub 2018 Aug 3.
- Background: PubMed 24564610Bockow R, Korostoff J, Pinto A, Hutcheson M, Secreto SA, Bodner L, Hersh EV. Characterization and treatment of postsurgical dental implant pain employing intranasal ketorolac. Compend Contin Educ Dent. 2013 Sep;34(8):570-6.
- Background: PubMed 20467629Alissa R, Sakka S, Oliver R, Horner K, Esposito M, Worthington HV, Coulthard P. Influence of ibuprofen on bone healing around dental implants: a randomised double-blind placebo-controlled clinical study. Eur J Oral Implantol. 2009 Autumn;2(3):185-99.
- Background: PubMed 17190305Hashem AA, Claffey NM, O'Connell B. Pain and anxiety following the placement of dental implants. Int J Oral Maxillofac Implants. 2006 Nov-Dec;21(6):943-50.
- Background: PubMed 17274712Al-Khabbaz AK, Griffin TJ, Al-Shammari KF. Assessment of pain associated with the surgical placement of dental implants. J Periodontol. 2007 Feb;78(2):239-46. doi: 10.1902/jop.2007.060032.
- Background: PubMed 28864284Samieirad S, Afrasiabi H, Tohidi E, Qolizade M, Shaban B, Hashemipour MA, Doaltian Shirvan I. Evaluation of caffeine versus codeine for pain and swelling management after implant surgeries: A triple blind clinical trial. J Craniomaxillofac Surg. 2017 Oct;45(10):1614-1621. doi: 10.1016/j.jcms.2017.06.014. Epub 2017 Jul 5.
- Background: PubMed 23772674Emecen-Huja P, Eubank TD, Shapiro V, Yildiz V, Tatakis DN, Leblebicioglu B. Peri-implant versus periodontal wound healing. J Clin Periodontol. 2013 Aug;40(8):816-24. doi: 10.1111/jcpe.12127. Epub 2013 Jun 18.
- 17 Dental Implant Industry Statistics and Trends.Link provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared. This is a pilot, exploratory study.
Related trials for Osseointegrated Dental Implantation
Enrolling by invitation
Prospective Longitudinal Clinical Study for the Evaluation of Peri-implant Tissue and Osseointegration After Rehabilitation With Osseointegrated Implants
Osseointegration Failure of Dental Implant, Periimplantitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliot V Hersh, DMD, MS, PhD principal investigator
University of Pennsylvania
Katherine N Theken, PharmD, PhD principal investigator
University of Pennsylvania School of Dental Medicine and Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen, Acetaminophen and Tramadol in people with Osseointegrated Dental Implantation and Pain, Acute, run by Hersh, Elliot V., DMD, MS, PhD at 1 site in United States.
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 5 inclusion and 11 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 16 May 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Intensity Scores on Numeric Pain Intensity Scale 0-6 Hours (time frame: Up to 6 hours). The study lists 4 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 NCT04694300, which also lists 18 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 16 May 2024.