Michael S. Reddy

Effects of periodontal therapy on rate of preterm delivery: A randomized controlled trial

OBJECTIVE: To test the effects of maternal periodontal disease treatment on the incidence of preterm birth (delivery before 37 weeks of gestation). METHODS: The Maternal Oral Therapy to Reduce Obstetric Risk Study was a randomized, treatment-masked, controlled clinical trial of pregnant women with periodontal disease who were receiving standard obstetric care. Participants were assigned to either a periodontal treatment arm, consisting of scaling and root planing early in the second trimester, or a delayed treatment arm that provided periodontal care after delivery. Pregnancy and maternal periodontal status were followed to delivery and neonatal outcomes until discharge. The primary outcome (gestational age less than 37 weeks) and the secondary outcome (gestational age less than 35 weeks) were analyzed using a χ2 test of equality of two proportions. RESULTS: The study randomized 1,806 patients at three performance sites and completed 1,760 evaluable patients. At baseline, there were no differences comparing the treatment and control arms for any of the periodontal or obstetric measures. The rate of preterm delivery for the treatment group was 13.1% and 11.5% for the control group (P=.316). There were no significant differences when comparing women in the treatment group with those in the control group with regard to the adverse event rate or the major obstetric and neonatal outcomes. CONCLUSION: Periodontal therapy did not reduce the incidence of preterm delivery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00097656. LEVEL OF EVIDENCE: I

The effect of nonsurgical periodontal therapy on hemoglobin a1c levels in persons with type 2 diabetes and chronic periodontitis a randomized clinical trial

IMPORTANCE Chronic periodontitis, a destructive inflammatory disorder of the supporting structures of the teeth, is prevalent in patients with diabetes. Limited evidence suggests that periodontal therapy may improve glycemic control. OBJECTIVE To determine if nonsurgical periodontal treatment reduces levels of glycated hemoglobin (HbA1c) in persons with type 2 diabetes and moderate to advanced chronic periodontitis. DESIGN, SETTING, AND PARTICIPANTS The Diabetes and Periodontal Therapy Trial (DPTT), a 6-month, single-masked, multicenter, randomized clinical trial. Participants had type 2 diabetes, were taking stable doses of medications, had HbA1c levels between 7% and less than 9%, and untreated chronic periodontitis. Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with 5 academic medical centers. INTERVENTIONS The treatment group (n = 257) received scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months. The control group (n = 257) received no treatment for 6 months. MAIN OUTCOMES AND MEASURES Difference in change in HbA1c level from baseline between groups at 6 months. Secondary outcomes included changes in probing pocket depths, clinical attachment loss, bleeding on probing, gingival index, fasting glucose level, and Homeostasis Model Assessment (HOMA2) score. RESULTS Enrollment was stopped early because of futility. At 6 months, mean HbA1c levels in the periodontal therapy group increased 0.17% (SD, 1.0), compared with 0.11% (SD, 1.0) in the control group, with no significant difference between groups based on a linear regression model adjusting for clinical site (mean difference, -0.05% [95% CI, -0.23% to 0.12%]; P = .55). Periodontal measures improved in the treatment group compared with the control group at 6 months, with adjusted between-group differences of 0.28 mm (95% CI, 0.18 to 0.37) for probing depth, 0.25 mm (95% CI, 0.14 to 0.36) for clinical attachment loss, 13.1% (95% CI, 8.1% to 18.1%) for bleeding on probing, and 0.27 (95% CI, 0.17 to 0.37) for gingival index (P < .001 for all). CONCLUSIONS AND RELEVANCE Nonsurgical periodontal therapy did not improve glycemic control in patients with type 2 diabetes and moderate to advanced chronic periodontitis. These findings do not support the use of nonsurgical periodontal treatment in patients with diabetes for the purpose of lowering levels of HbA1c. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00997178.

Influence of surface characteristics on survival rates of mini-implants.

OBJECTIVE To compare the clinical performance and the survival rate of two mini-implant systems with different surface characteristics under immediate orthodontic loading. MATERIALS AND METHODS Seventeen machined titanium (MT) mini-implants and 15 sandblasted, large grit, acid-etched (SLA) mini-implants were placed in 10 patients. The mini-implants were immediately loaded and the patients seen at 7, 14, 30, 60, and 150 days. Clinical parameters such as anatomical location, character of the soft tissue at the screw head emergence, type of mini-implant system, diameter, and length were analyzed. In addition, the insertion torque recorded at the time of insertion was also assessed. Survival rate and clinical parameters were evaluated by the chi-square exact tests using the SAS version 9.1. RESULTS The overall survival rate was 87.5%. Over the four failing mini-implants, three were MT and one SLA resulting in an individual survival rate of 82.4% and 93.4%, respectively. In the failure group, all the fixtures had their screw emergence at the oral mucosa and recorded a torque range of less than 15 Ncm. The insertion torque statistically influenced the survival rate of the mini-implants (P < .05). Surface treatment, anatomical location, as well as soft tissue emergence were not statistically significant. CONCLUSION Surface characteristics did not appear to influence survival rates of immediately loaded mini-implants.

Radiographic Methods in the Evaluation of Periodontal Therapy

Radiographic methods are commonly utilized to assess periodontal bone changes in clinical trials. Radiographs are unique as a data source in that they provide a permanent visual record of the bone support and allow for linear, area, and volume measurements of periodontal lesions. The major limiting factors in the use of radiographic outcomes measures are geometric distortion and radiographic processing errors. The use of standardized methods and computer algorithms has reduced the effect of these errors on data from radiographs. Radiographic analysis in clinical trials is largely done in digital format by indirect digitizing film with a video camera. Direct digital detectors are now available for intra-oral use. The use of a direct detector eliminates the need for film processing and allows for dose reduction. The detectors currently available are limited in size and resolution. Subtraction radiography allows for area and volume estimates of bone gain or loss. The subtraction methods are highly precise, but are also technically exacting and labor intensive. The clinical trial hypothesis, size, length, and accuracy required should be the final consideration in choosing a radiographic method. J Periodontol 1992; 63:1078-1084.

Platelet-Derived Growth Factor Promotes Periodontal Regeneration in Localized Osseous Defects: 36-Month Extension Results From a Randomized, Controlled, Double-Masked Clinical Trial

BACKGROUND Recombinant human platelet-derived growth factor (rhPDGF) is safe and effective for the treatment of periodontal defects in short-term studies up to 6 months in duration. We now provide results from a 36-month extension study of a multicenter, randomized, controlled clinical trial evaluating the effect and long-term stability of PDGF-BB treatment in patients with localized severe periodontal osseous defects. METHODS A total of 135 participants were enrolled from six clinical centers for an extension trial. Eighty-three individuals completed the study at 36 months and were included in the analysis. The study investigated the local application of β-tricalcium phosphate scaffold matrix with or without two different dose levels of PDGF (0.3 or 1.0 mg/mL PDGF-BB) in patients possessing one localized periodontal osseous defect. Composite analysis for clinical and radiographic evidence of treatment success was defined as percentage of cases with clinical attachment level (CAL) ≥2.7 mm and linear bone growth (LBG) ≥1.1 mm. RESULTS The participants exceeding this composite outcome benchmark in the 0.3 mg/mL rhPDGF-BB group went from 62.2% at 12 months, 75.9% at 24 months, to 87.0% at 36 months compared with 39.5%, 48.3%, and 53.8%, respectively, in the scaffold control group at these same time points (P <0.05). Although there were no significant increases in CAL and LBG at 36 months among all groups, there were continued increases in CAL gain, LBG, and percentage bone fill over time, suggesting overall stability of the regenerative response. CONCLUSION PDGF-BB in a synthetic scaffold matrix promotes long-term stable clinical and radiographic improvements as measured by composite outcomes for CAL gain and LBG for patients possessing localized periodontal defects ( ClinicalTrials.gov no. CT01530126).

Digital subtraction radiography for longitudinal assessment of peri-implant bone change: method and validation.

The purpose of this paper is to present a digital subtraction technique for the assessment of peri-implant bone change over time in vivo. Digital subtraction radiography may be used to detect areas of bony change that have occurred between radiographic examinations, and image processing algorithms have been developed which can relate the magnitude of the change on the subtraction image to a reference wedge, thereby allowing calculation of the mass of the lesion. This manuscript will present two algorithms for the assessment of osseous change. The method was validated in monkeys by means of small bony chips placed intra-orally prior to the first radiograph. The chips were removed, a second radiograph taken, and the images subtracted. Each algorithm was used to isolate the lesion and calculate change in bone mass. Overall, there was excellent correlation between the calculated lesion mass (in milligrams) and actual lesion mass (r2 > 0.9). The utility of the method was demonstrated by comparison of the results of subtraction radiography in successful implants and in implants that did not integrate during the healing phase.

Contrast enhancement as an aid to interpretation in digital subtraction radiography

An initial study was performed to demonstrate the feasibility of pseudocolor contrast enhancement technique in digital subtraction radiography (DSR). DSR is an electronic image processing technique that has been shown to be of greater diagnostic value in the detection of small periodontal bone lesions than conventional radiography. Pseudocolor enhancement involves selectively assigning a unique color to each shade of gray present in a black-and-white subtracted image. Two image enhancement techniques were developed and tested in a phantom system consisting of extracted teeth set in blocks of plaster mixed with sawdust to simulate trabecular bone. It was found that experimentally induced periodontal lesions were more readily detected by the average clinician in both types of enhanced subtraction images than unenhanced subtractions. Furthermore, both enhancement techniques were of significantly greater diagnostic value for lesions smaller than 1.0 mm (p less than 0.001). The technique that colored an isolated area of interest was significantly more diagnostic at all depths tested (p less than 0.001 at 0.5 and 1.0 mm, and p less than 0.05 at 0.5 mm). Contrast enhancement may be a significant aid to the average clinician for the interpretation of DSR and the detection of small periodontal defects.

Longitudinal Study of Bone Density and Periodontal Disease in Men

Bone loss is a feature of both periodontitis and osteoporosis, and periodontal destruction may be influenced by systemic bone loss. This study evaluated the association between periodontal disease and bone mineral density (BMD) in a cohort of 1347 (137 edentulous) older men followed for an average of 2.7 years. Participants were recruited from the Osteoporotic Fractures in Men Study. Random half-mouth dental measures included clinical attachment loss (CAL), pocket depth (PD), calculus, plaque, and bleeding. BMD was measured at the hip, spine, and whole-body, by dual-energy x-ray absorptiometry, and at the heel by ultrasound. After adjustment for age, smoking, race, education, body mass index, and calculus, there was no association between number of teeth, periodontitis, periodontal disease progression, and either BMD or annualized rate of BMD change. We found little evidence of an association between periodontitis and skeletal BMD among older men.

Semiautomated image registration for digital subtraction radiography

OBJECTIVE The purpose of this study was to evaluate the semiautomatic alignment and correction of affine geometric discrepancies for digital subtraction radiography. STUDY DESIGN Algorithms were tested in vitro to determine their ability to semiautomatically select reference points on a second image based on points selected on a first (reference) image. A preserved human mandible was imaged with and without bone-equivalent material chips at varying degrees of angulation. Each chip had a mass of less than 10 mg and was no more than 0.3 mm thick. High levels of specificity and sensitivity for chip detection were achieved with 6 degrees of angular discrepancy or less. The algorithms were then applied to radiographs from six human subjects through use of the bone-chip validation model. RESULTS Sensitivity was 89% and 100% for the three-point and four-point affine warp algorithms, respectively. Specificity for both algorithms was 100%. CONCLUSIONS The data indicate that semiautomated alignment algorithms may enhance the efficacy of digital subtraction radiography while maintaining diagnostic efficacy in clinical trials.

Radiographic Determinants of Implant Performance

This paper reviews and compares the strengths and weaknesses of radiographic techniques including periapical, occlusal, panoramic, direct digital, motion tomography, and computed tomography. Practical considerations for each method, including availability and accessibility, are discussed. To date, digital subtraction radiography is the most versatile and sensitive method for measuring boss loss. It can detect both bone height and bone mass changes on root-form or blade-form dental implants. Criteria for implant success have changed substantially over the past two decades. In clinical trials of dental implants, the outcomes require certain radiographic analyses to address the hypothesis or clinical question adequately. Radiographic methods best suited to the objective assessment of implant performance and hypothesis were reviewed.