CLOONAN ORAL HEALTH TRIAL FINDS THE ANSWER^® FOR CARE OF MEDICALLY COMPROMISED RESIDENTS

TRIAL RESULTS ARE SIGNIFICANT

Dr. Richard Cloonan, DDS and patent holder of the liquid combination toothpaste and mouthwash for medically compromised patients, was “cautiously optimistic” on September 2 at the start of the AHCA Oral Health Trial.  He confided, “In eight years of testing and development and five patents, I was confident that The Answer would improve oral health of medically compromised residents, reduce staff time in giving oral health care and offer a cost efficient alternative to traditional toothpastes.”

On January 20 Cloonan reported trial results to the AHCA board.  Cloonan was “pleased and gratified that the Oral Health Trial results showed statistically significant results.” He reported, “Both the Trial and Control Groups showed improvement in oral health care scores during the 90-day double blind trial.  The improvement among all the participants seems related to the consistent application of an oral health treatment.  However, those using The Answer (the Trial Group) showed a 31% improvement in both their plaque and gingivitis scores. This improvement was statistically significant in six of the seven trial facilities. ”

IMPLICATIONS TO ARKANSAS HEALTH CARE PROVIDERS

The AHCA-approved Oral Health Care Trial demonstrated that The Answer provided an alternative treatment for the oral health care of medically compromised residents that improved their oral health significantly, reduced the workload of health care staff to provide the service and offered a cost-effective tool.

Dr. Cloonan recognized the leadership of the AHCA board and staff in providing the opportunity to conduct the Oral Health Care trial. He said, “The AHCA board recognized the potential that The Answer offered to improve the oral health of medically-compromised residents of long-term care facilities.  By allowing The Cloonan Corporation, Dr. Jackie Smith (Trial Administrator) and Terrapin Consulting (Trial Manager) to conduct the clinical trial, the AHCA board and staff provided a real world test of the new product with traditional products and protocol.  As a result of their leadership, we can now report to them that we have statistically significant data showing that The Answer is “the answer” for health care providers to meet the challenge of Arkansas and Federal oral health standards, to improve staff utilization and to enhance the quality of life of residents.”

TRIAL PROTOCOL

Dr. Cloonan received the approval of the Arkansas Health Care Association board of directors to conduct the Oral Health Trial in member facilities on May 20, 2003.  

Following the board’s approval of the Oral Health Trial Dr. Cloonan received inquiries from five skilled nursing facilities seeking to participate in the study.  The Trial Manager, Walt Eilers, met with the facility administrators to outline the trial protocol and facility commitment.  All initial properties agreed to participate.  Two additional facilities were recruited by referral to broaden the variety of types of residents and nursing facility experiences. A total of seven facilities with a universe of 436 residents were included in the study. The 202 residents represent a 46% sample of the available universe.

Initially, 202 residents qualified for the study, completed the appropriate releases and were given a dental exam by the Trial Administrator, Dr. Jackie Smith.  

During the course of the trial a total of 29 of the original participants deceased, were hospitalized or withdrew from the facility and the study.  

A total of 173 residents in seven facilities completed the Oral Health Trial. Ninety residents were in the Control Group that continued their traditional oral healthcare practice and product(s). Eighty-three residents were in the Trial Group.  They exclusively used The Answer for their oral care.  The Trial Protocol called for these participants to follow the “swish-brush-swish” protocol each evening following the evening med rounds.

The Oral Health Trial is termed a “double blind study” in that at no time were the participants or their treatment identified to the Trial Administrator other than by room number.  

The Trial Administrator oriented the healthcare staff at each participating facility to the proper brushing and oral healthcare techniques for the trial.  Dr. Smith outlined The Answer protocol and demonstrated it on staff members during a 45-minute session. Two facilities requested additional training as a result of substantial staffing changes.

TRIAL OBJECTIVES PROVED

The research proposal approved by the AHCA board outlined four objectives.  The trial proved that The Answer satisfactorily addressed each objective.

Verify the ease of use to both the participant and caregiver.

·        95% of participants and staff responding to the trial concluding survey and interview indicated that The Answer was easier to use than traditional toothpastes.

·        The liquid toothpaste was preferable, tasty and attractive to all but one
participant interviewed.

·        The participants and staff found The Answer was easier to use than traditional toothpaste and was more effective in removing food scraps and plaque residue from the mouth.

·        The participants and staff commented that The Answer did not require the clean up and mess associated with traditional toothpastes.

Prove that the treatment protocol takes less than 5 minutes to complete daily.

·        All participants and staff agree that The Answer reduced the amount of time necessary to provide oral health care.

·        The staff estimated that they saved from 4 to 7 minutes per patient per treatment with The Answer. The primary reason was The Answer does not require cleanup and is easier to measure and administer.

·        Participants practicing self-care noted that The Answer was much more practical to use. The “swish” cleaned out large particles of food.  The brushing removed residue and the concluding “swish” washed away that debris.

Measure the effectiveness of The Answer in improving oral health.

·        The Control Group participants showed a 13.2% improvement in their Plaque and a 8.4% improvement in their Gingivitis scores for an average improvement of 10.8% compared to a composite Trial Group improvement of 31% in each. 

·        The overall oral health of the Control participants improved by 10.8% compared to a 31% improvement for the Trial participants.

·        The oral health improvement comparison between the two groups favors the Trial Group by a 20.2%difference.

·        Trial Group participants experienced an average difference of 17.8% improvement in their Plaque scores. ƒ Trial Group participants experienced an average difference of 22.6% improvement in their Gingivitis scores.

·        Six of the seven facilities showed statistically significant improvement in the oral health scores of the Trial Group participants.  The other facility trial sample was too small for t-test analysis.

·        Twelve of fourteen t-test analyses were significant. Ten of twelve t-score analyses were significant at the .01 level. Two were significant at the .05 level.

Demonstrate that the product provides improved dental health at under $10 per month per patient.

·        The trial cost per treatment was $.21 including The Answer product and the toothbrush.

·        The monthly cost per patient for 31 treatments was $6.51.

TRIAL FINDINGS

·        The Answer Trial Group participants experienced greater improvement in both their plaque and gingivitis scores than those in the Control Group.

·        The range of improvement difference for the Trial Group was a 17.8% Plaque improvement and 22.6 Gingivitis improvement. Their overall oral health scores improved 20.2% compared to the Control Group.

·        The Trial Group improvement was statistically significant in twelve of fourteen instances. Two instances had a sample too small to calculate the t-score.  Ten of the twelve instances of significant t-scores were at the .01 level and the remaining two at the .05 level.

·        The greatest improvements were in a setting in which the participants and staff was committed to the protocol and consistently applied it.

·        Higher functioning participants welcomed The Answer.  They easily adapted to the “swish, brush and swish” protocol in preference to the normal brushing regimen.

·        During the trial, the majority of all participants showed improvement in their oral health. The distinguishing factor is the consistency of oral health care generated by the Oral Health Care Trial.

·        Three contrary situations were encountered in the trial:

·        Low functioning dementia participants were inclined to swallow The Answer when it was offered without careful and extensive coaching by the staff member.

·        A limited number (less than 2%) of the participants were physically unable to swish and required staff direct intervention with moistened toothettes to use The Answer.

·        Participants with a history of discipline or anxiety were reluctant to try the new product and required additional staff attention at the start of the trial.

TRIAL CONCLUSIONS

o       Those participants using the trial product (The Answer) consistently showed a greater improvement in their oral health during the trial than those using traditional product.

o       The oral health of those using the trial product (The Answer) improved at a significant level compared to traditional products.

o       The Oral Health Care Trial results support the observation that oral health improvement (i.e., decrease in plaque and gingivitis scores) seems to be directly related to the consistency of the application of an oral care protocol.  In facilities in which the staff or participants consistently followed a protocol both the Trial and Control group scores improved.  The Trial Group scores improved more than the Control Group scores.

o       Even in the instances of inconsistent application of oral health care protocol, Trial Group scores out performed those of the Control Group and showed a statistical significance. This consistent pattern leads the Trial Administrator and Trial Manager to conclude that the product (The Answer) made the difference even when used inconsistently.

o       Those two facilities that used the Trial protocol two times each day (evening meds and after breakfast) showed a greater oral health improvement that the Trial groups maintaining the once-a-day protocol and significantly better than the improvement of all Control Groups.

o       The Trial Administrator observed that the incidence of oral ulcers and gingival redness reduced during the trial because of consistent oral health care.

o       The regular turn over of nursing and support staff requires easy access to educational and technical support through emails, website or telephone consultations to assure continuing education and meet the needs of the changing staff.

o       The Trial Group results (The Answer participants and protocol) demonstrated an effective means for long-term care facilities to meet and exceed the requirements of Federal Oral Health standard 317.

o       Given the significant results of the AHCA Oral Health Trial, a request to the Office of Long Term Care should garner an approval for Medicare reimbursement status for improved oral health care.

TRIAL RESULTS

PLAQUE MOUTH AVERAGE

GINGIVITIS MOUTH AVERAGE

TRIAL COMPOSITE CHANGE RESULTS

Note: The composite facility pre and post averages are the “mouth averages” for each participant averaged by the concluding sample for that facility.  Any patient who deceased, was hospitalized or moved from the facility was removed from the calculation.

TRIAL ACKNOWLEDGEMENTS

·        The successful conclusion of the Oral Health Care Trial was the result of the cooperation and efforts of a number of individuals associated with the Arkansas Health Care industry.

·        Randy Wyatt, Executive Director of AHCA for guidance and support.

·        Wes Robertson, President of Group Purchasing of Arkansas, for recommendations, guidance and support.

·        Elizabeth Andrioli and Debby Thetford Nye of Mitchell Williams Selig Gates Woodyard PLLC for assistance in developing the release and consent forms.

·        Thanks to the seven facility administrators and staff for support and involvement:

·        Dusty Maxwell, Gwen McKinnon and Donna Gustafson of Pathfinder

·        Carol Richards and Ruby Khan of Robinson Nursing and Rehabilitation